EMC ® Documentum ® Electronic Trial
Master File
Version 3.1
User Guide
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Table of Contents
Preface
Chapter 1
Chapter 2
Chapter 3
.................................................................................................................................
7
......................................................................................................
9
TMF Structure ..................................................................................................
10
File Plans .........................................................................................................
13
Registration Forms ...........................................................................................
15
Overview
Trial Activation using File Plan Templates ..........................................................
16
File Plan Template Updates while Trials are Active .............................................
18
Progress Tracking .............................................................................................
18
Trial Schedule Adjustments ...............................................................................
Trial Registration Form Lifecycle Model .............................................................
20
21
Trial Suspension and Locking ............................................................................
22
...........................................................................................................
User Roles ........................................................................................................
Trial Managers and Product Managers ...............................................................
Contributors and Investigators ..........................................................................
Authors and Document Coordinators ................................................................
Reviewers and Approvers .................................................................................
Inspectors and Auditors ....................................................................................
Readers ............................................................................................................
Administrators .................................................................................................
25
Roles
Set Up and Administer Trials
25
27
27
28
29
30
30
30
....................................................................... 33
Defining Information in Registration Forms .......................................................
Creating a Product Registration Form ............................................................
Creating a Clinical Trial Registration Form .....................................................
Creating a Country Registration Form ...........................................................
Creating a Site Registration Form ..................................................................
Restricting Access to Registration Forms ........................................................
Assign Users and Groups to their Roles .........................................................
33
34
35
36
37
38
38
External Trial Participant Registrations ..............................................................
Security Considerations for Internal and External Users ..................................
Giving Access to External Trial Participants ....................................................
Verifying External Trial Participant Access .....................................................
39
40
41
42
Creating a File Plan...........................................................................................
Creating a File Plan Template ........................................................................
File Plan Template Activation ........................................................................
Activating the File Plan Template ..................................................................
Creating Registration Forms for the Trial ........................................................
Associating a File Plan Template with a Product Registration Form .................
42
43
45
45
46
46
3
Table of Contents
Chapter 4
Chapter 5
4
Associating a File Plan Template with a Trial Registration Form ......................
Associating a File Plan Template with a Country Registration Form .................
Associating a File Plan Template with a Site Registration Form ........................
Building the File Plan for the Trial..................................................................
File Plan Validation.......................................................................................
Validating the File Plan .................................................................................
Adjusting the Trial Schedule..........................................................................
Activating the File Plan for a Clinical Trial .....................................................
Activating the Trial .......................................................................................
eTMF Folder Structure ..................................................................................
Product-level TMF Placeholders and Documents ............................................
47
47
48
48
48
49
50
50
51
51
52
Updating the eTMF Structure with Changes .......................................................
53
Viewing Clinical Trial Progress ..........................................................................
53
Locking a Clinical Trial .....................................................................................
53
Registration Form Changes that apply to Existing Documents .............................
Changing a Product Code for a Product .........................................................
Combining Products .....................................................................................
Changing Product-related Information for a Product ......................................
Changing the Therapeutic Area for a Product .................................................
Changing Clinical Trial Information ...............................................................
Moving Trial Documents to a Different Product ..............................................
Changing the Location of a Site .....................................................................
Changing the Name of a Site .........................................................................
54
54
55
56
57
58
59
59
60
..............................................................
Import and Indexing Process .............................................................................
Placeholders .....................................................................................................
Finding a Placeholder .......................................................................................
Finding a Placeholder using a Public Search .......................................................
Viewing Placeholder Properties .........................................................................
Finding a Registration Form ..............................................................................
Import Documents............................................................................................
Importing from the Welcome Page .................................................................
Importing to a Placeholder ............................................................................
Importing to a Registration Form ...................................................................
Indexing a Document in the Finalize Indexing List..............................................
Indexing a Document in the Document List ........................................................
Finding a Document .........................................................................................
63
...............................................................................
Controlled Documents ......................................................................................
Creating a Document ....................................................................................
File Naming and Versioning ..............................................................................
Omitting a Placeholder .....................................................................................
Reinstating a Placeholder ..................................................................................
Document Updates ...........................................................................................
Editing a Document ......................................................................................
Checking in a Document ...............................................................................
Sharing a Document across Sites ....................................................................
Configuring Content Templates .........................................................................
Creating a Content Template .........................................................................
71
Import and Index Trial Documents
Create Trial Documents
63
65
65
65
66
66
67
67
67
67
68
68
69
71
72
73
74
74
74
74
75
75
75
76
Table of Contents
Chapter 6
Chapter 7
Modifying a Content Template ......................................................................
77
Importing and Exporting Multiple Documents ...................................................
Creating a TMF Bulk Import-Export Package for a Trial ..................................
Refreshing the Value Assistance for the Bulk Import-Export
Spreadsheet .................................................................................................
Zip and Export the TMF Bulk Import-Export Package .....................................
Populating the Bulk Import-Export Spreadsheet .............................................
Importing the Document Package ZIP File .....................................................
Starting the Bulk Import of Documents ..........................................................
79
80
Review and Approve Trial Documents
81
81
83
85
85
......................................................... 87
Workflow Process .............................................................................................
87
Document Review and Approval .......................................................................
Launching the Collaborative Editing Workflow ..............................................
Launching the Review Workflow ...................................................................
Self-approving a Document ...........................................................................
88
89
89
90
Performing Tasks in a Workflow ........................................................................
Viewing the Audit Trail.................................................................................
Categorizing Inbox Tasks ..............................................................................
90
90
91
Processing Documents in a Workflow ................................................................
Collaborative Editing ....................................................................................
Editing a Document in a Workflow ................................................................
Incorporating Document Changes .................................................................
Reviewing Documents in a Review Task ........................................................
Reviewing Document Feedback from Reviewers ............................................
Approving Documents .................................................................................
Working with Final Documents .........................................................................
Suspending a Document ...............................................................................
Withdrawing a Document .............................................................................
Deleting Documents Permanently..................................................................
Superseded Documents ................................................................................
93
93
93
94
94
95
96
96
96
96
97
97
Viewing Document Status .................................................................................
Viewing Workflow Progress ..............................................................................
98
98
Workflow Task Performer Changes ....................................................................
Updating Workflow Task Performers .............................................................
Stopping a Workflow ..................................................................................
Delegating a Task as a Workflow Supervisor ................................................
Delegating a Task as a User .........................................................................
Reassigning Roles .......................................................................................
99
99
100
100
101
101
............................................................................................
Locating Documents .......................................................................................
Finding Documents ....................................................................................
Viewing Documents and their Properties .........................................................
Viewing Documents Side-by-side ....................................................................
Adding Notes.................................................................................................
Viewing and Deleting Notes ............................................................................
Viewing the Document History .......................................................................
Export the Document List to Microsoft Excel ....................................................
103
Inspect a Trial
103
103
104
104
104
104
104
104
........................................................................................ 107
Chapter 8
Find Documents
Chapter 9
View Trial Master File Reports
................................................................... 111
5
Table of Contents
Chapter 10
Overview of the TMF Reports..........................................................................
111
Viewing Dashboard Reports ............................................................................
112
Product - Trials Table ......................................................................................
114
Product - Trials by Status ................................................................................
115
Trial - Missing Documents Table ......................................................................
117
Trial - Missing Documents by Zone ..................................................................
118
Trial - Missing Documents by Status ................................................................
119
Trial - Full Inventory Table ..............................................................................
120
Trial - Received Documents by Status...............................................................
121
Trial - Progress History ...................................................................................
122
Trial - Schedule Status by Stage .......................................................................
123
Trial - Site Status .............................................................................................
124
Site - Full Inventory Table ...............................................................................
125
Document Control
127
Documentum eTMF User Groups ....................................................................
Cross-functional User Groups .....................................................................
Reporting Groups .......................................................................................
Clinical User Groups ..................................................................................
128
129
129
130
External Trial Participant Roles ........................................................................
External Trial Participant Groups .................................................................
130
131
Document Lifecycle Model ..............................................................................
Trial Master File Document Lifecycle States ..................................................
Trial Master File Document Lifecycle ...........................................................
Registration Form Lifecycle Models .................................................................
Product Registration Form Lifecycle ............................................................
Clinical Trial Registration Form Lifecycle .....................................................
Clinical Trial Country Registration Form Lifecycle ........................................
Clinical Trial Site Registration Form Lifecycle ...............................................
134
134
135
137
137
139
140
141
Additional Menu Functions.............................................................................
Additional Menu Functions for Trial Registration Forms ...............................
Additional Menu Functions for TMF Placeholders ........................................
Additional Menu Functions for TMF Documents ..........................................
Permissions ....................................................................................................
Trial Master File Document Permissions .......................................................
Product Registration Form Permissions ........................................................
Clinical Trial Registration Form Permissions.................................................
Country and Site Registration Form Permissions ..........................................
142
142
143
144
145
146
147
147
148
................................................................................................. 149
For Collaborative Editing ................................................................................ 149
Submit Document for Review .......................................................................... 150
Chapter 11
Workflows
Chapter 12
Troubleshooting
6
..................................................................................... 127
Control Categories ..........................................................................................
........................................................................................ 151
Verifying User Roles ....................................................................................... 151
Connection Issues ........................................................................................... 151
Preface
This guide describes the default behavior of EMC Documentum Electronic Trial Master File
(Documentum eTMF), part of the EMC Documentum for Life Sciences solution suite. This solution is
built on the Documentum D2 web application and Documentum platform.
Documentum D2 is a web-based application that enables users to store, retrieve, and manage
documents in a Documentum repository. It is highly customizable through a configuration
application that does not require programming knowledge. Documentum D2 consists of the
following components:
• Documentum D2 Configuration (D2 Config): The configuration application that enables you to
configure settings for security, workflows, document classification, and the client user interface.
• Documentum D2 Client (D2 Client): The main application that is used to interact with
documents in the repository.
Additional Documentum D2 components that are used in Documentum eTMF are:
• Documentum D2 Office Integration (O2): Microsoft Office and Outlook properties
synchronization for documents and email.
• Documentum D2 PDF Integration (C2): PDF file control for watermarking and controlled
printing.
Intended Audience
This guide is intended for those who use the EMC Documentum Electronic Trial Master File solution,
part of the EMC Documentum for Life Sciences solution suite.
Revision History
7
Preface
8
Revision Date
Description
June 2016
Added a note about annotations not supported
in Excel on PowerPoint native formats in Editing
a Document in a Workflow, page 93.
October 2014
Initial publication
Chapter 1
Overview
The Trial Master File (TMF) is a centralized global repository of documents related to a clinical study
or trial. Researchers use the terms clinical study and clinical trial interchangeably. Throughout
the lifetime of a drug product or treatment, investigators can initiate any number of trials in order
to prove the safety and efficacy of the therapy. These studies generate significant amounts of
documentation, which must be stored in the TMF for compliance purposes.
Some of these documents are submissible and must be included in regulatory submissions to a health
authority in order to gain approval for sale of the drug product. Other documents in the TMF provide
supporting evidence, but they are not part of the regulatory submissions. The health authority
usually mandates that organizations retain the entire TMF throughout the lifetime of the product.
The health authority can inspect and audit the TMF documents at any time.
The EMC Documentum Electronic Trial Master File (Documentum eTMF) solution, part of the EMC
Documentum for Life Sciences solution suite, enables Life Sciences organizations to address the
challenge of capturing, collating, storing, securing, and retaining massive amounts of documents
from clinical studies conducted at numerous sites and countries around the world. Documentum
eTMF, built on Documentum, is used in enterprise-scale information management applications in
Life Sciences and supports TMF management in conformance with the latest industry standards.
With this solution, you can:
• Plan your TMF for clinical trials based on predefined file plan templates
• Provide placeholders for clinical document authors, study monitors, and other participants to
find, upload, and create content
• Bulk-upload existing or externally-produced documents, such as documents delivered by external
Contract Research Organizations (CROs)
• Obtain document metadata automatically to facilitate search and discovery and to reduce the
need for manual data entry
• Use predefined review and approval workflows, electronic sign-off, and secure auditing to enable
21 CFR-11 compliance
• Monitor the progress of clinical trials globally
• Extend trials to new countries and new sites
• Delegate planning to national country and local site managers while maintaining centralized
control to ensure compliance
• Facilitate Inspection-Readiness through collection, completion, and missing document reporting
on Products, Trials, and Sites
9
Overview
• Manage access to trials based on user roles
• Lock down trial-related documents when the trial is complete
• Integrate the solution with your Clinical Trial Management System (CTMS) in order to
synchronize CTMS-controlled information with your Documentum eTMF system
This section contains the following topics:
• TMF Structure, page 10
• File Plans, page 13
• Registration Forms, page 15
• Trial Activation using File Plan Templates, page 16
• File Plan Template Updates while Trials are Active, page 18
• Progress Tracking, page 18
• Trial Schedule Adjustments, page 20
• Trial Registration Form Lifecycle Model, page 21
• Trial Suspension and Locking, page 22
TMF Structure
The organization of the TMF is fully configurable, but the standard installation has filing areas, zones,
and sections. Each section contains one or more artifacts (document types). The standard installation
supports all of the zones, sections, and artifacts defined in the DIA TMF 2.0 reference model.
The TMF supports the following filing areas:
• Central Trial Documents: Contains global trial-level documents applicable to all countries and all
sites for a particular trial, except when you specify otherwise.
• Country-specific: Contains national documents. These artifacts are applicable to all sites within
a particular country. A trial can have several country-specific filing areas. The system can
automatically create a separate filing area for each country conducting a trial.
• Site-specific: Contains site-specific artifacts that are applicable to an individual site. The system
can automatically create a separate filing area for each site conducting a trial.
Above the trial level, there is an additional General Documents filing area that enables the filing of
product-level (or compound-level) documents. These documents pertain to all trials conducted for
the product and are therefore shared across the trials.
The following figure illustrates the folder structure in the standard installation grouped by
therapeutic area, product code, and trial phase within the Clinical cabinet:
10
Overview
You can change the general filing structure and naming conventions by modifying the Documentum
D2 auto-filing and auto-naming rules using Documentum D2 Configuration, known as D2 Config.
For example, in a small-to-medium size organization, you can remove the top-level therapeutic area
(product group) folders to make it easier to navigate the structure. Similarly, if you do not want to
group the TMF folders by study phase, you can remove the clinical study phase folder level so that
the TMF folders for each study appear directly underneath the product folder.
The following figure shows the filing areas for each trial:
11
Overview
Each filing area is divided into zones and sections containing the artifacts (TMF documents), which
by default are named and numbered in accordance with the DIA TMF reference model. This is
predefined in a Documentum D2 taxonomy (the TMF Classification by Artifact taxonomy). End users
do not have to think about TMF document naming and numbering conventions or where they should
put documents in the structure. They select the appropriate artifact name (document type) and the
system auto-files, numbers, and names the document in accordance with the preconfigured taxonomy.
The following figure shows the predefined TMF Classification by Artifact taxonomy in Documentum
D2 (viewed as a Microsoft Excel spreadsheet):
12
Overview
You can modify and extend the taxonomy using D2 Config. The standard installation contains a
predefined DIA TMF 2.0 reference model. You can extend the taxonomy to include customer-specific
artifacts or to support additional reference models. Documentum eTMF supports multiple reference
models, so you can implement the latest standard reference models as they emerge or provide
different reference models for different parts of the business using their own terminology.
File Plans
The system generates the folder structure automatically according to a predefined file plan. A file
plan is a Microsoft Excel spreadsheet specifying the expected artifacts in each filing area. The file
plan specifies whether artifacts are required (must-have), recommended (should-have), or optional
(could-have) documents. Before activating the trial, Trial Managers usually set up the file plan based
on predefined templates. The file plan also specifies the cardinality rules for each artifact. Cardinality
rules define whether each artifact is repeatable (more than one document can be provided) and
the minimum number of expected documents in each case. The system uses this information to
determine the level of completion of each artifact.
The following figure shows an example Microsoft Excel spreadsheet file plan:
13
Overview
In the Scope column of the file plan, you can specify:
• Product: Defines a product-level artifact filed in the General Documents filing area.
• Trial: Defines a Central Trial Documents artifact.
• All Countries: Defines a country-level artifact for each country conducting a trial.
• Specific Country: Defines an individual country-level artifact for a particular country.
• All Sites: Defines a site-level artifact for each site conducting a trial, which you can restrict to
a particular country.
• Specific Site: Defines an individual site-level artifact for a particular site.
You can also redefine the same artifact at different levels in separate rows of the spreadsheet. For
example, you can define an artifact that is required at the trial level and optional at the site level.
Creating a File Plan, page 42 provides more information on configuring and using file plan
spreadsheets.
When you activate a trial, the system processes the file plan spreadsheet. This processing includes
creating placeholder documents (or just placeholders) for each expected artifact, filing those
placeholders into the configured folder structure, assigning security to the folders and placeholders,
and enabling the collection of documents for that trial. This folder structure helps document
contributors to identify the documents they should provide and upload the relevant content file
into each placeholder.
As end users upload content for the placeholders, the system automatically removes the placeholders
as appropriate. Repeatable artifacts enable users to provide multiple documents for the same artifact.
Each document is automatically given a unique item number (or sequence number) in that case,
which is appended to the standard artifact number. The system retains the placeholder to enable
the uploading of additional documents until the expected number is reached, at which time the
14
Overview
placeholder is removed. If a repeatable placeholder has an expected count of "0" (infinite), the system
never automatically removes the placeholder.
Placeholders enable the system to track the progress of the TMF and to identify missing documents
in the reports. The placeholders can be empty (no-content) documents or they can provide initial
content, such as a blank form for the users to fill in. In the standard installation, the placeholders are
generated as contentless objects. To provide initial content, you can configure content templates for
each artifact, or for a set of artifacts, and enable them for use with the relevant placeholders. The
placeholders also provide most of the required document attributes automatically, so users only need
to enter document-specific metadata.
Configuring Content Templates, page 75 provides more information.
End users do not need to create and manage, or even be aware of, the folder structure. The system
generates it automatically based on the predefined file plan. If the file plan changes or the trial
extends to new countries and sites, the system recognizes that new placeholders are required for the
new artifacts and creates the corresponding folders for the new countries and sites automatically.
If end users delete documents, the system automatically regenerates placeholders for the missing
documents.
The TMF reconciliation process completes these tasks. It compares the current state of the TMF with
its file plan, generates any missing placeholders, removes placeholders that are no longer required,
and updates the progress statistics on the registration form for the trial. The validity and progress
of each entry in the file plan automatically synchronizes the status with the master file plan. They
can use this information to identify and correct file plan configuration errors. They can also use the
feedback for detailed progress monitoring of active trials.
Registration Forms
EMC Documentum Electronic Trial Master File uses Registration Forms to model the entities and
their metadata which make up a clinical trial. Documents and placeholders inherit registration form
metadata when they are associated to one of these entities.
There are four types of registration forms related to TMFs:
• Product Registration Form: Registers product codes and product-specific information, such as
chemical names, trade names, and generic names.
• Clinical Trial Registration Form (Trial Registration Form): Registers individual trials. Each trial
is associated with a product registration and must have a unique trial ID.
• Country Registration Form: Registers the countries where the sites participating in a trial are
located. A trial can have multiple Country Registration Forms, but each Country Registration
Form is associated to one trial.
• Site Registration Form: Registers the individual sites that participate in the trial. Just as for
Country Registration Forms, a trial can have multiple Site Registration Forms, but each Site
Registration Form pertains to one trial and must relate to a pre-registered country (a Country
Registration Form) for that trial. This means that if the same site participates in three different
trials, there will be three registration forms for that site - one for each trial.
The relationships between the various registration forms define a hierarchy that reflects the structure
of the TMF as shown in the following figure:
15
Overview
In the preceding example, product X registers with three trials (CTX0001, CTX0002, and CTX0003).
The first trial is in one site only, in the US. The second is in two separate sites within the US. The third
is in two separate sites in different countries – one in Sweden (SV) and one in Germany (DE).
You can create these registration forms manually and maintain them directly in Documentum
using the D2 Client application. You can also create all types of registration forms automatically
through the TMF Software Development Kit (SDK), a Web Services API that enables Documentum to
synchronize with Clinical Trial Management Systems (CTMS). The SDK allows CTMS to create and
update registration forms in the Documentum eTMF system. And changes to those registration forms
are automatically represented in your trial. For example, if a new site is recruited for an ongoing trial,
that information is entered into your CTMS system. The CTMS issues a call to the TMF SDK, creating
the site registration form. The TMF reconciliation method runs and creates the placeholders and
folders for the new site. The reports automatically update (because the placeholders and registration
forms exist), and collection of the expected documents can begin.
Using the TMF SDK to integrate with your CTMS system requires development effort. For additional
assistance, contact EMC IIG Professional Services.
Trial Activation using File Plan Templates
Activating a Trial Registration Form causes the system to generate the initial TMF structure, based on
its file plan, and to monitor the progress of the TMF in relation to the file plan. You always activate
TMFs at the Trial Registration Form level and not at the Product, Country, or Site level. Activating a
Product, Country, or Site Registration Form makes that registration form available for use. It does not
cause the system to generate any TMF placeholders.
At a minimum, you must create a Product Registration Form and a Trial Registration Form for
each trial. You must create a file plan at the Trial Registration Form level before activating the trial.
Country and Site Registration Forms are optional and can be added incrementally. However, if you
16
Overview
know the initial countries and sites conducting the trial in advance, it is better to establish country
and site registrations for them before activating the trial. This enables you to add country-specific
and artifact-specific artifacts to the file plan. In the absence of country and site registrations, you can
only add All Countries and All Sites entries to the file plan. These artifacts then apply to all countries
and sites that are later registered, which may not be your intent.
The file plan is stored as the main content of the Trial Registration Form in Documentum, in Microsoft
Excel format. While you can build the file plan from scratch, users typically compile it from a set of
predefined file plan templates associated with the various registration forms. A file plan template is a
predefined file plan spreadsheet defining a subset of the artifacts that are normally associated with a
particular product, trial, country, or site. Although you always activate trials at the trial level, it is
possible to associate file plan templates with registration forms at any level.
If you use predefined file plan templates at various levels, you can build a default file plan for a trial
automatically before activating it. To create a default file plan, you use the Load File Plan context
menu option, which is available after you select a Trial Registration Form. This option compiles a
file plan in top-down order from any file plan templates associated with registration forms for the
trial at the product, trial, country, and site levels. You must have at least one product-level file plan
template or trial-level file plan template to create a file plan. File plan templates at the country
and site levels are optional.
The default file plan at the trial level can inherit parts of the file plan templates from other levels.
The following figure provides an example of how the system compiles the default file plan for a trial
from a hierarchy of file plan templates:
It is not necessary to define file plan templates at all levels. In practice, Trial Managers are most likely
to create file plan templates only at the product level and in some cases at the trial level. You can use
17
Overview
product-level file plans to provide a list of standard artifacts that usually apply to all trials related
to a particular product, or set of related products, and make these default rules (overridable) or
mandatory rules (non-overridable) to enforce compliance with business policies. It is also possible to
delegate file planning to the regions using country-level and site-level file plans, if necessary.
File Plan Template Updates while Trials are
Active
If you update a file plan template, for example, with the addition of planned artifacts, the new artifacts
can transfer automatically into the file plans for the active trials that refer to those templates. These
file plan updates result from the cumulative update feature of the trial reconciliation process. It is
optional and enabled by default, but you can disable it using D2 Config, if necessary. When enabled,
the reconciliation process checks the relevant file plan templates at each level on each cycle (those
that make up the default file plan) and ensures that none of the artifacts listed on those templates are
missing from the current file plan. If they are missing, the system adds the missing artifacts to the file
plan before validating and reconciling it. In this way, the system includes all new file plan template
entries in the file plans for the active trials that refer to them. However, existing entries in the file plan
do not change. If Trial Managers change the default file plan, their changes are preserved.
Likewise, if Trial Managers delete rows from the file plan, the system can add the deleted rows
back to the file plan automatically on the next reconciliation cycle if they are present in a file plan
template. You can prevent this by changing the inclusion rule setting to Not Required for the relevant
artifacts, instead of deleting them completely. The reconciliation process ignores these entries and
automatically deletes any placeholders that exist for them.
You should mark artifacts as Not Required in the file plan instead of deleting them. This preserves
a record of the artifacts that were originally in the file plan in case you decide to reinstate them in
the future.
Progress Tracking
The trial reconciliation process creates missing placeholders and removes placeholders that are no
longer required. The trial reconciliation process also finds completed documents in the TMF and
compares the number of completed documents for each artifact with the expected document count in
the corresponding row of the file plan. The process uses this information to determine how many
documents are missing or how many additional completed documents over and above the expected
number exist, if any. Additional completed documents count as extra documents but do not influence
the overall level of progress. For example, if 4 documents are expected for a particular artifact and 3
complete documents are provided, the artifact is 75% complete. If 4 documents are provided, it is
100% complete. If 5 documents are provided, it is still 100% complete, with 1 extra document.
A document is complete if it is both Current (the latest version) and Final (in the Final lifecycle state).
Work-in-progress documents (index and draft documents), non-current versions, and withdrawn
documents are not complete. After you upload documents into the system, end users must review,
approve, and mark them as Final before the system counts them as complete.
18
Overview
The system records progress information automatically in three places:
• In the Trial Registration Form properties, you can view progress summary statistics using the
Progress Summary menu option of the registration form.
• In the tmf_progress_history registered table in Documentum, information can be used to create
trend reports (progress history over time).
• In the file plan spreadsheet, the Status column for each row contains progress information, if
available. In this way, the file plan spreadsheet acts as a detailed progress report.
The following figure shows a progress statistics example for a trial:
The following example shows progress details for each artifact recorded in the file plan (viewed in
Microsoft Excel):
19
Overview
Trial Schedule Adjustments
In the Trial Registration Form properties, or through the Adjust Schedule menu option, you can time
constrain the trial by entering planned start and end dates for each stage in the file plan.
The following figure shows an example of defining a trial schedule:
With this trial scheduling information, the system can report on overall progress and can indicate
whether the trial is on track (condition Green), close to limits (Amber), or behind schedule (Red),
depending on the current progress compared to the expected progress over time. The system allows
for a certain amount of slack time at the start of the trial, during which no progress is expected to
allow for setup and initial document preparation. It projects the expected level of progress for the
currently active stage depending on the elapsed time since the planned start date. If progress is above
this limit, the system sets the condition code to Green. If progress is just below the limit, it sets the
condition code to Amber. If progress is well below the limit, it sets the condition code to Red. Trial
Managers can use this information to assess the general risk of overrun for the trial. This is just an
indication of the risk of overrun and may not necessarily be cause for concern, given that documents
are often completed and uploaded in batches.
You do not have to plan a trial in stages. For example, you can put all of the artifacts in a file plan in
stage 1. However, planning a trial in stages enables each stage to activate sequentially or in parallel
and you can track the overall progress of each stage. For example, you can put all of the initial
trial set-up artifacts in stage 1, the main artifacts in stage 2, and the finalization (trial closeout and
20
Overview
summary reporting) artifacts in stage 3. Then you can activate stage 2 (roll over the trial to the next
stage) when the stage 1 artifacts are completed.
Trial Registration Form Lifecycle Model
Trial Registration Forms have a predefined lifecycle configuration to enable Clinical Trial Managers to
manage the TMF in an orderly way.
The following figure illustrates the lifecycle state transitions:
In this figure, the solid lines represent lifecycle menu actions that Trial Managers who are assigned
to the form can perform. The Unlock function is a special case. It is further restricted to members
of the Controlled Document Administrators group (cd_admingroup). In order to unlock a locked
trial, users must be members of this group in addition to being a Trial Manager. The dotted lines
21
Overview
represent lifecycle transitions carried out automatically by the system on completion of the process.
The Initializing, Refreshing, Locking, and Unlocking states are transitory states, indicating that the
system is processing the TMF in the background.
The display does not refresh automatically when background processing completes, so the status
of the registration form may have changed without indication. Users can force a display refresh by
clicking the current folder icon in the folder tree browser.
The preceding figure does not show some functions that do not cause the status of the Trial
Registration Form to change: Load File Plan, Validate, Adjust Schedule, Progress Summary, and the
standard functions including Edit, Check out, and Check in. The Load File Plan function appears as
Reload File Plan in the context menu while the trial is active to emphasize the fact that it can replace
the existing file plan (subject to user confirmation). You should preserve a copy of the current file
plan by creating a new version of the Trial Registration Form before using this function.
EMC Documentum Electronic Trial Master File provides a Documentum D2 Batch Lifecycle
configuration to enable you to activate, refresh, and roll over Trial Registration Forms automatically
on a schedule, as required. For example, you can refresh the TMFs automatically using an overnight
job. It is very important that you schedule the Documentum D2 Batch Lifecycle job to run during
quiet periods, if possible, in order to minimize the impact of this additional background processing
on the end users.
Trial Suspension and Locking
You may need to suspend document preparation activity temporarily for a particular study during
an investigation or audit. A Trial Manager can suspend a trial by changing the Trial Registration
Form status from Active to Suspended using the Suspend menu option. While the Trial Registration
Form is in the Suspended state, the system prevents additional documents related to that trial from
changing to the Final state. Auditors and investigators scrutinize the current set of Final documents,
but they do not usually have access to other documents, such as work-in-progress versions.
End users can continue to upload work-in-progress documents and send them for review and
approval. If they try to make new documents Final (including new versions of existing documents),
they receive a message indicating that they cannot make the document Final because the associated
trial is currently suspended. In this way, the trial suspension protects the set of Final documents for a
study. Once the investigation or audit completes, the Trial Managers can revert the Trial Registration
Form to the Active state using the Resume menu option. In the Active state, end users can continue
to make additional documents Final.
In addition to suspending a trial, Trial Managers can also lock the trial using the Lock menu option.
Locking a trial causes all of the documents associated with the trial as well as the Trial Registration
Form to lock. Once locked, end users cannot edit or modify the documents. The file plan also locks
because of this process. Locking does not prevent users from uploading additional work-in-progress
documents, but like a suspended trial, the system prevents them from making new documents Final.
Trial Managers usually lock trials when they are complete to preserve the final set of documents.
It is possible to reverse the process by unlocking the trial, if necessary, to enable further document
changes. In the standard installation, the Unlock function is restricted to those Trial Managers who
22
Overview
are also members of the Controlled Document Administrators group (cd_admingroup). These Trial
Managers should only use the Unlock function in exceptional circumstances.
23
Overview
24
Chapter 2
Roles
This section contains the following topics:
• User Roles, page 25
• Trial Managers and Product Managers, page 27
• Contributors and Investigators, page 27
• Authors and Document Coordinators, page 28
• Reviewers and Approvers, page 29
• Inspectors and Auditors, page 30
• Readers, page 30
• Administrators, page 30
User Roles
EMC Documentum Electronic Trial Master File provides defined user roles that enable or restrict user
access to documents and information in the system. The following table describes the user roles:
User Role
Groups
Description
Managers
cd_product_managers
Create and manage registration forms for
each domain. For example, the Clinical
Trial Managers create clinical trial, country,
and site registration forms. Clinical Trial
Managers also set up and maintain the file
plan for a trial.
cd_clinical_trial_managers
Contributors
cd_clinical_doc_contributors
Import and index Trial Master File (TMF)
documents.
Authors
cd_clinical_doc_authors
Create documents and submit them for
collaborative editing and review. Authors
can also import documents like the
Contributors. Authors can self-approve
most TMF documents.
25
Roles
User Role
Groups
Description
Document
Coordinators
cd_clinical_doc_coordinators
Manage the publication of controlled
documents.
Authors can act as Document Coordinators
on most TMF documents.
Reviewers
cd_clinical_doc_reviewers
Review documents using annotations and
edit documents.
Approvers
cd_clinical_doc_approvers
Responsible for approving controlled
documents.
Auditors
cd_clinical_doc_auditors
Have read-only access to audit logs as
well as Final, Superseded, and Expired
documents.
Readers
cd_clinical_doc_readers
Have read-only access to Final versions and
are considered general consumers.
Investigator*
tmf_investigators
Clinical investigators who administer the
drug or therapy to subjects (patients or
volunteers) and record clinical data on
each subject. Investigators typically act as
contributors to the TMF.
Inspector*
tmf_inspectors
Health authority or regulatory agency
representatives who may audit a clinical
trial. Inspectors are typically given
read-access to Final documents in the TMF.
External
Contributor*
tmf_external_contributors
Produces documents or imports eTMF
documents. For example, a member of a
Contract Research Organization.
External Reviewer*
tmf_external_reviewers
Peer reviews or participates in collaborating
on documents. For example, an expert in
the relevant field of medicine.
Administrator
cd_admingroup
Accesses administrative functions but does
not have access to controlled documents.
*These roles are external participants. They can receive access to documents associated with a country
or site. The use of the term external does not require the user to be a contractor or otherwise external
to the system. It means that they do not have global access to all documents in the system and only
have access to what managers specifically grant to them. Managers can grant the access for a limited
time. External Trial Participant Roles, page 130 provides more information.
26
Roles
Related topic:
• Documentum eTMF User Groups, page 128
Trial Managers and Product Managers
Trial Managers and Product Managers manage the documentation for their respective areas. They
create and manage the registration forms that users use to import and create documents. They also
manage the placeholders for Trial Master File (TMF) documents. For example, Product Managers
manage product registration forms and Clinical Trial Managers, known as Trial Managers, manage
clinical trial, country, and site registration forms. Clinical Trial Managers also set up and maintain the
file plan for clinical trials and monitor the progress of active trials.
The following table lists Trial Manager tasks and provides links to the instructions:
Task
Instructions
Set up and manage registration forms
Defining Information in Registration Forms,
page 33
Assign users and groups to the default roles on
the registration forms
Assign Users and Groups to their Roles, page 38
Register external trial participants
External Trial Participant Registrations, page 39
Create file plans for clinical trials
Creating a File Plan, page 42
Update clinical trials
Updating the eTMF Structure with Changes,
page 53
Monitor clinical trial progress
Viewing Clinical Trial Progress, page 53
Make registration form changes that apply to
exiting documents
Registration Form Changes that apply to
Existing Documents, page 54
Import and export multiple documents
Importing and Exporting Multiple Documents,
page 79
Import and Index documents
Chapter 4, Import and Index Trial Documents
Create documents
Chapter 5, Create Trial Documents
View document status
Viewing Document Status, page 98
Find documents using Public searches
Chapter 8, Find Documents
Contributors and Investigators
Contributors, External Contributors, and Investigators import and index Trial Master File (TMF)
documents. They can use the quick action buttons on the Welcome page to import and index the
documents. The Welcome page also contains a status that shows the number of documents that
are ready for indexing.
27
Roles
Contributors can browse the eTMF structure; search for placeholders, registration forms, and
documents; drag and drop files on the placeholders; and index the files. Chapter 4, Import and Index
Trial Documents provides more information.
The following table lists Contributor, External Contributor, and Investigator tasks and provides
links to the instructions:
Task
Instructions
Search for placeholders
Finding a Placeholder, page 65
Finding a Placeholder using a Public Search,
page 65
Search for registration forms
Finding a Registration Form, page 66
Import documents
Importing to a Placeholder, page 67
Importing to a Registration Form, page 67
Index documents
Indexing a Document in the Finalize Indexing
List, page 68
Indexing a Document in the Document List,
page 68
Search for documents
Finding a Document, page 69
Authors and Document Coordinators
Authors create documents and submit them for collaborative editing and review. They can
self-approve most TMF documents.
Documentum eTMF has a Contributor role in addition to the Author role, which only import
documents. Authors can import documents and create documents from templates.
Document Coordinators manage the publication of controlled documents. Authors can act as
Document Coordinators on most TMF documents.
Authors and Document Coordinators monitor the progress of document workflow tasks. They can
change workflow task performers and stop the workflows.
The following table lists Author and Clinical Coordinator tasks and provides links to the instructions:
Task
Instructions
Create controlled documents
Creating a Document, page 72
Import and Index documents
Chapter 4, Import and Index Trial Documents
Send a document for collaborative editing
Launching the Collaborative Editing Workflow,
page 89
Send a document for review
Launching the Review Workflow, page 89
Self-approve documents
Self-approving a Document, page 90
28
Roles
Task
Instructions
Edit a document in a collaborative editing
workflow
Editing a Document in a Workflow, page 93
Incorporate document changes from each
reviewer
Incorporating Document Changes, page 94
Review document feedback from reviewers
Reviewing Document Feedback from Reviewers,
page 95
Approve TMF documents in a Review workflow
Approving Documents, page 96
Work with Final documents
Working with Final Documents, page 96
View the document history
Viewing the Audit Trail, page 90
View document status
Viewing Document Status, page 98
View workflow progress
Viewing Workflow Progress, page 98
Change workflow task performers
Workflow Task Performer Changes, page 99
Manage placeholders
Placeholders, page 65
Viewing Placeholder Properties, page 66
Omitting a Placeholder, page 74
Reinstating a Placeholder, page 74
Find documents using Public searches
Chapter 8, Find Documents
Reviewers and Approvers
Reviewers review documents using annotations and edit documents. Approvers are responsible
for approving controlled documents. Authors can self-approve most TMF documents. External
Reviewers peer review or collaborate during the authoring of documents. For example, an external
reviewer can be an expert in the relevant field of medicine.
Reviewers and Approvers complete workflow tasks and can browse and search for TMF documents.
The following table lists Reviewer tasks and provides links to the instructions:
Task
Instructions
Performing workflow tasks
Performing Tasks in a Workflow, page 90
Review and edit documents in a collaborative
editing workflow
Editing a Document in a Workflow, page 93
Review and annotate documents in a workflow
Reviewing Documents in a Review Task, page 94
View document status
Viewing Document Status, page 98
Delegate a task to another user
Delegating a Task as a User, page 101
29
Roles
Inspectors and Auditors
Inspectors and internal Clinical Auditors have read-only access to audit logs as well as Final,
Superseded, and Expired documents. They can view document content, history, and properties. The
Concurrent View enables them to compare two documents side-by-side. They can also add notes,
also known as Inspector Notes, to documents.
The following table lists Clinical Inspector and Auditor tasks and provides links to the instructions:
Task
Instructions
Browse and search for TMF documents
Locating Documents, page 103
Compare two documents side-by-side
Viewing Documents Side-by-side, page 104
Add a note, delete a note, and view notes
Adding Notes, page 104
Viewing and Deleting Notes, page 104
View the document history
Viewing the Document History, page 104
View document properties
Viewing Documents and their Properties, page
104
Export content to Microsoft Excel
Export the Document List to Microsoft Excel,
page 104
Readers
Readers have read-only access to Final versions of documents. They browse for, search, and read
documents. If any documents are category 1 and issue To Be Read (TBR) notifications, readers may
receive a workflow task to acknowledge the TBR.
The following table lists Reader tasks and provides links to the instructions:
Task
Instructions
Browse and search for TMF documents.
Locating Documents, page 103
Performing workflow tasks
Performing Tasks in a Workflow, page 90
Administrators
Administrators can access administrative functions, but they do not have access to controlled
documents.
30
Roles
The following Administrator tasks are available in the Administration view (known as the
Administration widget):
• Administer group membership
• Administer dictionaries
• Administer taxonomies
The EMC Documentum D2 User Guide provides more information.
31
Roles
32
Chapter 3
Set Up and Administer Trials
This section is for Trial Managers, also known as Business Administrators, who set up and administer
clinical trials. It is also for Product Managers who set up and manage product registration forms.
This section contains the following topics:
• Defining Information in Registration Forms, page 33
• External Trial Participant Registrations, page 39
• Creating a File Plan, page 42
• Updating the eTMF Structure with Changes, page 53
• Viewing Clinical Trial Progress, page 53
• Locking a Clinical Trial, page 53
• Registration Form Changes that apply to Existing Documents, page 54
Defining Information in Registration Forms
Managers have the ability to create registration forms, which model trial entities in the Trial Master
File (TMF) system. New documents inherit specific attribute values from registration forms when
users create or import documents in the repository. Registration forms enable users to create
documents with consistent and accurate properties. Registration forms also correctly assign users for
each role in the workflow.
While managers have the ability to manually create registrations, most of the information supplied
in these forms is managed by other systems such as Clinical Trial Management System (CTMS) or
master data management system. Therefore, Documentum eTMF supplies an SDK to integrate
external systems and allow those systems to create and manage registration forms.
Registration forms are not versioned. Before using a registration form to create documents, verify
that all of the information is consistent and accurate. When you change registration form properties,
the changes usually apply to the documents that users create after the change. However, Product
Managers and Trial Managers can make changes that apply to existing documents.
33
Set Up and Administer Trials
Registration forms:
• Define the product codes and trial identifiers that can be selected in the document properties
screens in the Classification tab when a new document is created.
• Provide default metadata for the relevant documents and placeholders to inherit, which may be
read-only at the document/placeholder level.
• Simplify the document creation process for the Authors by reducing data entry.
• Restrict the use of certain product codes and trial IDs to specific user groups.
• Define default role assignments to apply to the relevant documents, which can be read-only at
the document level.
• Enable the appropriate managers to control of the overall status of a product, trial, or project.
• Can disable an entire product or trial by preventing documents from being made Final.
Registration Forms, page 15 provides additional information.
The following topics describe how to create registration forms:
• Creating a Product Registration Form, page 34
• Creating a Clinical Trial Registration Form, page 35
• Creating a Country Registration Form, page 36
• Creating a Site Registration Form, page 37
Creating a Product Registration Form
Product Registration Forms define product codes and product-related metadata. These forms relate
products to the appropriate therapeutic areas and are required to create the Clinical Trial Registration
Forms.
1.
Log in as a member of the cd_product_managers group.
2.
From the Repository browser, navigate to the Product Library and select a related Product
Registration Form.
3.
Select New > Content from the menu bar.
4.
In the Creation profile field, select Product Management.
5.
In the Document Type field, select Product Registration Form and click Next.
6.
On the Edit properties page, select or type information in the fields associated with following tabs:
• Registration: Provide information to identify the product.
• Product Info: Enter values to the DIA Reference Model specified attribute information for the
product.
34
Set Up and Administer Trials
• Trial Master Files:
— Enable product-level file plan: Select to associate a predefined product-level file plan
template with this form. This field is optional and can be set up after you create the form.
— TMF Template: If you enable a product-level file plan, select a file plan template. You can
only use a product-level file plan template that is in the Active state.
• Access Control:
— Product Managers: Add the users who can manage this registration form. Add the
managers to the to the cd_product_managers group, if necessary.
— Primary User Group: Add the groups that can author documents related to the Product
Registration Forms. You should test the registration form before allowing users to access it.
Hover your cursor over the fields to show additional information.
7.
Click Next.
The system saves the form in the Product Library cabinet. The initial status is In Development.
Related topic:
• Product Registration Form Lifecycle, page 137
Creating a Clinical Trial Registration Form
The Clinical Trial Registration Form defines clinical trial metadata, including product-related
metadata, which documents related to a particular clinical trial can inherit.
1.
Verify that the file plan template is in the Active state if you plan to associate the Clinical Trial
Registration Form with a file plan template.
2.
Log in as a member of the cd_clinical_trial_managers group.
3.
From the Repository browser, navigate to the Product Library and select a related Product
Registration Form.
4.
Select New > Content from the menu bar.
5.
In the Creation profile field, select Clinical Trial Management for eTMF.
6.
In the Document Type field, select Trial Registration Form and click Next.
7.
On the Registration tab, type or select information to identify the trial. The Clinical Trial
Identifier (Clinical Trial ID) is case sensitive. For example, if there is already a Clinical Trial ID
named Abc, the system allows you to create a Clinical Trial ID named abc.
35
Set Up and Administer Trials
8.
To associate a file plan template with the registration form, select Enable TMF file planning and
in the TMF Template field, select the file plan template.
9.
Verify the information on the Trial Info, Access Control, and Default Users / Groups tabs. These
tabs inherit information from the Product Registration Form.
You can specify default TMF Authors in the Default Users / Groups tab. This setting only applies
to the Trial Master File placeholder documents generated by the system when the Clinical Trial
Registration Form is activated. The default setting for this field is cd_clinical_doc_authors, which
means that all members of the Clinical Document Authors group can edit and replace the content
of the system-generated TMF placeholders. You can also create an Authors sub-group for a
particular trial and configure it using this setting.
10. If you enable TMF file planning, on the Trial Master File tab:
a.
Select the number of planned stages.
b. In the Time constraints area, select whether to time constrain the trial. If the trial is
time-constrained, provide planned start and end dates for each stage together with a slack
period (to allow for set up and initial document preparation). Associating a File Plan
Template with a Trial Registration Form, page 47 provides more information.
c.
If you select Staged - planned start /end dates defined for each range, select how to activate
the trial.
d. If you select more than one planned stage, in the Rollover field, select how to move to the
next stage.
e.
Select the Activation Level for the TMF file plan. This controls the overall scope of the file
plan. The system ignores artifacts below the selected activation level. For example, if you
select Trial, the TMF file plan ignores country and site-level artifacts.
11. Click Next.
The system saves the form in the Clinical Trial Library cabinet. If the directory structure does
not exist, the system creates it. The initial status is Planning.
Related topics:
• Clinical Trial Registration Form Lifecycle, page 139
• Additional Menu Functions for Trial Registration Forms, page 142
Creating a Country Registration Form
Clinical Trial Country Registration Forms (Country Registration Forms) register the countries which
will have sites participating in a particular clinical trial so that you can plan and upload country and
site-specific documents for that trial. Country Registration Forms are unique to a particular trial and
you cannot reuse them across trials. For example, if you have sites in Germany participating in two
clinical trials, you will need to have two country registration forms for Germany, one for each trial.
You can add Country Registration Forms at any time, either before activating the trial or while the
trial is active. For example, you can add Country Registration Forms as the trial rolls out to new sites
in new countries. You can then register sites for each country. Creating a Site Registration Form, page
37 provides additional information.
36
Set Up and Administer Trials
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
From the Repository browser, navigate to the Clinical Trial Library and select a related Trial
Registration Form.
3.
Select New > Content from the menu bar.
4.
In the Creation profile field, select Clinical Trial Management for eTMF.
5.
In the Document Type field, select Country Registration Form and click Next.
6.
On the Registration tab, type or select information in the fields as needed.
7.
To associate this form with a predefined country-level file plan template:
a.
On the Trial Master File tab, select Use country-level TMF file plan.
b. In the TMF Template field, select the file plan template.
8.
Verify the information on the Access Control tab. It inherits information from the Trial
Registration Form.
9.
Click Next.
The system saves the form in the Clinical Trial Library cabinet. If the directory structure does not
exist, the system creates it. The initial status is Active.
Related topic:
• Clinical Trial Country Registration Form Lifecycle, page 140
Creating a Site Registration Form
Clinical Trial Site Registration Forms (Site Registration Forms) register the sites which will participate
in a particular clinical trial so that you can plan and upload site-specific documents for that trial. Site
Registration Forms are unique to a particular trial and you cannot reuse them across trials. For
example, if you have the same site participating in two clinical trials, you need to have two site
registration forms, one for each trial.
You can add Site Registration Forms at any time, either before activating the trial or while the trial is
active. For example, you can add Site Registration Forms as the trial rolls out to new sites. A site
name and Principal Investigator is associated with each site to facilitate site identification.
Register the country in which the site resides before registering the site. Creating a Country
Registration Form, page 36 provides additional information.
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
From the Repository browser, navigate to the Clinical Trial Library and select a related Country
Registration Form.
3.
Select New > Content from the menu bar.
4.
In the Creation profile field, select Clinical Trial Management for eTMF.
5.
In the Document Type field, select Site Registration Form and click Next.
6.
On the Registration tab, type or select information in the fields as needed.
7.
To associate this form with a predefined site-level file plan template:
37
Set Up and Administer Trials
a.
On the Trial Master File tab, select Use site-level TMF file plan.
b. In the TMF Template field, select the file plan template.
8.
Verify that the information is correct on the Access Control tab. It inherits information from the
Country Registration Form.
9.
Click Next.
The system saves the form in the Clinical Trial Library cabinet. If the directory structure does not
exist, the system creates it. The initial status is Active.
Related topic:
• Clinical Trial Site Registration Form Lifecycle, page 141
Restricting Access to Registration Forms
Administrators can restrict access to Registration forms using the following methods:
• Control user access: Restrict access to registration forms by creating specific group forms for
the appropriate functional area group. For example, set up a confidential trial that consists of
documents visible to a new group with specified users. Then define this group as the Clinical
Trial Managers on the Access Control tab of the Trial Registration Form. Only these users can
view the registration form and create documents that refer to this trial. Additional restrictions
can also be imposed by changing the lifecycle state of the form.
• Control lifecycle states: By changing the lifecycle status of a registration form, administrators
can preserve the current set of Final documents relating to a particular product, trial, or project.
The project, trial, or entire product line is frozen when the associated registration forms in one
of these states.
— Clinical Trial Registration Form: Restrict access to a Trial Registration Form by changing the
status of the form to Halted or Completed. Documents referring to a particular Trial cannot be
made Final while the Trial is in a Halted or Completed state.
— Product Registration Form: Restrict access to a Product Registration Form by changing the
status of the form to Suspended or Withdrawn. Documents referring to a particular Trial
Registration Form cannot be made Final while the Product Registration Form is in a Suspended
or Withdrawn state.
While the registration form remains frozen, users can create, review, and approve documents.
However, users cannot release the documents to a Final state until the appropriate registration
forms are reverted to an Active state.
Assign Users and Groups to their Roles
Use this procedure to change the default users and groups assigned to the roles on the Clinical Trial,
Country, or Site Registration Forms.
Log in as a member of the cd_clinical_trial_managers group.
1.
38
Right-click a Clinical Trial, Country, or Site Registration Form and select Properties.
Set Up and Administer Trials
2.
On the Default Users / Groups tab, select the users and groups for the default roles that appear
when users create documents that refer to this registration form. For example, On the Reviewers
tab, select the default users and groups responsible for reviewing the documents created with
this registration form. Authors can adjust these settings when they create documents.
3.
Click OK.
External Trial Participant Registrations
Managers can give external trial participants TMF access at the site and country levels by adding them
to the relevant registration forms at those levels. Registering participants at the site level provides
access to the documents and placeholders for that site, as well as the documents and placeholders
for the country, trial, and product associated to the site. Registering participants at the country level
provides access to the documents and placeholders for that country, all sites registered for that
country, and to the trial and product documents and placeholders to which the country is registered.
External trial participant roles include inspectors, investigators, external contributors, and external
reviewers. Administrators can define additional roles, if necessary. The document access for a
particular role depends on the registration form used to provide the access:
• Site-level registration form: Provides access to the documents and placeholders for that site, as
well as the documents and placeholders for the country, trial, and product associated to the site.
• Country-level registration form: Provides access to the documents and placeholders for
that country, all sites registered for that country, and to the trial and product documents and
placeholders to which the country is registered.
You can also limit the duration of the access for external trial participants. You can define when the
access begins and when it expires. For example, in preparation for an inspection, a clinical trial
manager adds an inspector for a specified time for a set of studies.
When a clinical trial manager activates a site or country registration form, the system automatically
creates a hierarchy of access control groups for the external trial participants.
The following figure illustrates the access control group hierarchy for external trial participants:
39
Set Up and Administer Trials
The system only adds users to a participant role group if their registration is valid as defined by
the registration form manager. The registration form and its associated trial registration form, if
applicable, must also be active. If a trial registration form is no longer active, such as when it is in a
Planning state, the system revokes access to all participants. If the trial registration form reactivates,
the groups repopulate to reinstate access.
Related topics:
• External Trial Participant Roles, page 130
• External Trial Participant Groups, page 131
• Security Considerations for Internal and External Users, page 40
• Giving Access to External Trial Participants, page 41
• Verifying External Trial Participant Access, page 42
Security Considerations for Internal and External Users
Trial Managers can add internal users as external trial participants for a particular site or country.
When trial managers grant internal users additional access rights as external trial participants,
Documentum security grants the users the highest level of security. For example, if an internal user
with Read access becomes an External Contributor for a specific site, the user has Read access to
everything and receives Write access to specific site documents and to country, trial, and product
documents related to that site.
40
Set Up and Administer Trials
Giving Access to External Trial Participants
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
Locate a site-level or country-level registration form for a particular trial. The selected country
or site registration form must be in the Active lifecycle state.
3.
Right-click the registration form and select Manage External Participants.
4.
Complete the external participant information as defined in the following table:
Column
Description
User Name Begins
Enter the first few letters of the user name to
filter your selection options in the User Name
field.
User Name
Select the Documentum user name of the
participant for the selected registration form.
Full name
Displays the real-life name of the selected
Documentum user.
Email Address
Displays the email address of the participant.
Role
Select the role of the participant for the
country or site.
Valid From
(Optional) Select the date that the access of the
participant begins.
Valid To
(Optional) Select the date that the access of the
participant expires.
Enable
Select the checkbox to enable system access for
the participant as specified in the country or
site registration form.
Clear the checkbox to remove access for the
participant.
Status
Displays whether the participant is currently
enabled in the system. If the participant is
enabled in the system, the status is Active. If
the participant is not enabled in the system,
the status is Inactive.
5.
To add another participant below another participant, right-click a row and select Insert row. To
remove a participant, right-click a row and select Delete row.
6.
To provide access to documents for another site or country repeat this procedure using a relevant
site or country registration form.
7.
Click OK.
8.
Right-click the registration form again and select Manage External Participants. Verify that the
status of the participants is correctly set to Active or Inactive in the Status column.
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Set Up and Administer Trials
Related topic:
• Verifying External Trial Participant Access, page 42
Verifying External Trial Participant Access
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
Browse or search for a country-level or site-level registration form for a particular trial.
3.
Right-click the registration form and select Manage External Participants.
4.
In the Status column, verify that the status of the participants is correctly set to Active or Inactive
in the Status column.
5.
Adjust the participant settings as required.
6.
Click OK.
7.
If you changed participant access settings, right-click the registration form again and select
Manage External Participants. Verify that the updated statuses appear correctly as Active or
Inactive in the Status column.
Creating a File Plan
A Trial Master File (TMF) is a compilation of essential documents that get collected as a clinical
trial progresses in order to ensure regulatory compliance. A file plan enables you to specify the
relevant document types (artifacts) that users should provide at each stage of the clinical trial. The file
plan also enables you to define a hierarchical file structure and metadata for the documents at the
following levels in the TMF structure:
• Product
— Trial
— Country
— Site
After you create and activate the file plan, it automatically creates the hierarchical file structure and
the document placeholders for all active stages within the file structure. Contributors and Authors
create and import documents and associate them to the placeholders. TMF system properly names,
files, and secures the documents.
A file plan is always associated with a clinical trial and is stored as a Microsoft Excel file of the Trial
Registration Form. Depending on the configuration, the file plan can cover all of the levels in the
file structure (Product, Trial, Country, and Site) by using TMF templates. TMF templates, known
as file plan templates, associate with registration forms at one or more levels in the hierarchical
structure to update and maintain the file plan.
File Plan Templates are Microsoft Excel spreadsheets that contain the TMF Taxonomy (Schema) that
enables you to select and plan the document types for the trial. The system compiles the file plan from
file plan templates starting with the product-level file plan template (if there is one), followed by the
trial-level file plan template, any country-level file plan template, and any Site-level file plan template.
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Set Up and Administer Trials
A file plan should have at least one file plan template defined at the Product or Trial level. In most
situations, you create a file plan from either a product-level file plan template or a trial-level file plan
template:
• Product-level file plan template: Defines artifacts that should apply to all trials related to a
particular product. You can require or recommend specific artifacts at the product level to ensure
compliance with business rules or practices. You can redefine recommended product artifacts at
the trial, country, and site levels when necessary.
• Trial-level file plan template: Defines artifacts for an individual trial. If you have multiple trials,
consider creating multiple trial-level file plan templates to define common artifacts for different
types of trials. You can then select the appropriate trial level template when creating a file plan
for a trial.
File Plans, page 13 provides detailed information.
Complete the following procedures to create a file plan from a product-level or trial-level file plan
template:
• Creating a File Plan Template, page 43 (Create a file plan template at the product level or trial
level.)
• Activating the File Plan Template, page 45
• Creating Registration Forms for the Trial, page 46
• Associating a File Plan Template with a Product Registration Form, page 46 (For a product-level
file plan template)
• Associating a File Plan Template with a Trial Registration Form, page 47 (For a trial-level file
plan template)
• Building the File Plan for the Trial, page 48
• Validating the File Plan, page 49
• Adjusting the Trial Schedule, page 50
• Activating the Trial, page 51
Creating a File Plan Template
A file plan should have at least one file plan template defined at the Product or Trial level. In most
situations, you create a file plan from either a product-level file plan template or a trial-level file plan
template.
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
Select New > Content from the menu bar.
3.
In the Creation profile field, select Clinical Trial Management for eTMF.
4.
In the Document Type field, select Template File Plan and click Next.
5.
In the Level field, select the level that the template applies to in the file structure.
6.
In the Template Name field, type a name for the file plan template. The file plan template
applies to all trials.
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Set Up and Administer Trials
7.
On the Access Control tab, verify the default access. It restricts access to the file plan.
8.
Click Next, select the File Plan Sample Spreadsheet, and then click Next.
9.
If requested, select a folder on your local file system for your checked out content on the local
file system.
10. On the File Plan worksheet of the blank TMF Master Template Microsoft Excel spreadsheet, select
information from the drop-down lists as described in the following table:
File Plan Column Name
Description
Stage
(Optional) Leave this field blank or select a relevant
stage number. You can use up to five stages.
You can assign each row to a stage. When activating
the trial, you get an option to activate the stages. You
can activate the stages incrementally or in parallel.
Artifact Name
Unique artifact name as defined in the taxonomy.
Inclusion Rule
Shows whether the artifacts are required,
recommended, or optional.
Scope
Shows the level in the hierarchical file structure
(product, trial, country, or site) for each artifact. If you
select All Countries or All Sites, the system creates a
unique placeholder for each country or site registered
for the trial.
Country (where applicable)
This field is only used when the Scope field is Specific
Country.
Site (where applicable)
This field is only used when the Scope field is Specific
Site.
Repeatable?
• Select Y (Yes) to allow more than one document for
the placeholder.
• Select N (No) to allow only one document for the
placeholder.
Expected # docs (per location)
Minimum number of documents expected for the
placeholder to be regarded as complete:
• If Repeatable is No and this field is 0, the artifact is
considered optional. If Repeatable is Yes and this
field is 0, the artifact is considered infinite meaning
that the system never removes the placeholder and
the artifact shows as missing until the placeholder is
omitted. Select 0 for optional documents.
• Select 1 or more for repeatable required documents.
Can be overridden
44
• Select Y (Yes) to allow users to redefine this artifact
in a lower-level file plan template.
Set Up and Administer Trials
File Plan Column Name
Description
• Select N (No) to prevent users from redefining
this artifact. In that case, users can contact the
appropriate manager to make changes.
11. Do not update the columns to the right of the Can be overridden? column. The system uses the
Validity, Locations, Status, and Source columns to record validation errors, placeholder counts,
current progress, and template source origin information.
12. Do not update the Schema worksheet. The system automatically updates the schema. The
information in the drop-down lists on the File Plan worksheet comes from the schema.
13. Save the Microsoft Excel Spreadsheet in Microsoft Excel 97-2003 format (.xls format).
14. On the Check in page, click Check In and Finish. The file plan template has a status of Planning.
The system saves the file plan template in the Clinical Trial Library/Templates folder. Users
cannot use the file plan template until it is set to Active.
File Plan Template Activation
You can only use file plan templates in the Active lifecycle state. This enables you to edit and review
them before making them active.
Only one version of a file plan template can be Active at any time. If you edit the Active version and
check-in the changes to create a new version, your new version reverts to the Planning state. The
system uses the previous Active version until the next version becomes Active, at which point the
previous Active version becomes Superseded. The system always uses the latest Active version of
the file plan template.
You associate the file plan template with a registration form at the same level in the hierarchical
structure. Registration forms hold attributes values that documents inherit. Your file plan template
must have an Active version before you can associate it with a registration form.
You can withdraw a file plan template at any time. The system withdraws all versions when you
do this, including the currently Active version.
Trial Activation using File Plan Templates, page 16 provides additional information.
Activating the File Plan Template
1.
In the Repository browser, navigate to the Clinical Trial Library/Templates folder and locate
the file plan template.
2.
To activate the file plan template, right-click the file plan template and select Activate. Select
Yes to confirm.
To withdraw the file plan template at any time, right-click the file plan template and select
Withdraw.
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Set Up and Administer Trials
Creating Registration Forms for the Trial
Create trial and product registration forms for the trial. Country and site registration forms are
optional. You must associate at least one file plan template with the Product Registration Form or the
Clinical Trial Registration Form. You do not have to associate file plan templates at the lower levels
(Country Registration Form and Site Registration Form). If you associate file plan templates at the
lower levels, the file plan templates merge together to update the file plan.
1.
Create a Product Registration Form. Creating a Product Registration Form, page 34 provides
instructions.
• If you have a Product-level file plan template, associate it with the Product Registration
Form. Associating a File Plan Template with a Product Registration Form, page 46 provides
instructions.
2.
Create a Clinical Trial Registration Form. Creating a Clinical Trial Registration Form, page 35
provides instructions.
• If you have a trial-level file plan template, associate the trial-level file plan with the Clinical
Trial Registration Form. Associating a File Plan Template with a Trial Registration Form, page
47 provides instructions.
3.
Create a Clinical Trial Country Registration form (optional). It is not necessary to associate it with
a file plan template. Creating a Country Registration Form, page 36 and Associating a File Plan
Template with a Country Registration Form, page 47 provide instructions.
4.
Create a Clinical Trial Site Registration form (optional). It is not necessary to associate it with
a file plan template. Creating a Site Registration Form, page 37 and Associating a File Plan
Template with a Site Registration Form, page 48 provide instructions.
Trial Activation using File Plan Templates, page 16 and Registration Forms, page 15 provide more
information.
Associating a File Plan Template with a Product
Registration Form
To use TMF file planning, associate at least one file plan template at the product or trial level (Product
Registration Form or Clinical Trial Registration Form). If you have a product-level file plan template,
associate it with a Product Registration Form.
1.
Right-click a Product Registration Form and click Properties.
2.
On the Trial Master Files tab of the Edit Properties page, select Enable product-level file plan.
3.
In the TMF Template field, select the product-level file plan template.
4.
If you are unable to select the product-level file plan template as expected in a registration form,
on the Document list for the file plan template, verify that the status is Active.
5.
Click OK.
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Set Up and Administer Trials
Associating a File Plan Template with a Trial
Registration Form
To use TMF file planning, associate at least one file plan template at the product or trial level (Product
Registration Form or Clinical Trial Registration Form). If you do not have a product-level file plan
template defined, associate the trial-level file plan template with a Clinical Trial Registration Form.
1.
Right-click a Clinical Trial Registration Form and select Properties.
2.
On the Registration tab, select Enable TMF file planning.
3.
In the TMF Template field, select the trial-level file plan template.
4.
On the Trial Master File tab:
a.
Select the number of planned stages.
b. In the Time constraints field, select whether to time constrain the trial.
• If the trial is time-constrained, you can provide planned start and end dates for each stage
together with a slack period (to allow for set up and initial document preparation). The
system determines whether or not trial progress is on track based on the elapsed time
and it assigns condition codes:
— Green: On track
— Amber: Close to limits (slight risk)
— Red: Behind schedule (serious risk)
Condition codes appear in the eDRG reports.
• If the trial is not time-constrained, you do not enter planned start and end dates. The
system measures progress in terms of the number of documents completed compared to
the number expected, but it does not assign a condition code.
c.
If you select Staged - planned start /end dates defined for each range, select how to activate
the trial.
d. If you select more than one planned stage, in the Rollover field, select how to move to the
next stage.
e.
Select the Activation Level for the file plan template. This controls the overall scope of the
file plan. The system ignores artifacts below the selected activation level. For example, if you
select Trial, the file plan template ignores country and site-level artifacts.
You can change the activation level at any time. For example, you can change the activation
level to Site to increase the scope of the trial to include country and site-level artifacts.
5.
Click OK.
Associating a File Plan Template with a Country
Registration Form
1.
Right-click a Clinical Trial Country Registration Form and click Properties.
2.
On the Trial Master File tab, select Use country-level TMF file plan.
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3.
In the TMF Template field, select the country-level file plan template.
4.
Click OK.
Associating a File Plan Template with a Site Registration
Form
1.
Right-click a Clinical Trial Site Registration Form and click Properties.
2.
On the Trial Master File tab, select Use site-level TMF file plan.
3.
In the TMF Template field, select the site-level file plan template.
4.
Click OK.
Building the File Plan for the Trial
The file plan building process compiles a file plan from the relevant file plan templates and discards
the current file plan if there is one. You can preserve a copy of the current file plan for future
reference. To do this, check out the Clinical Trial Registration Form and check it in again to create
another version before using this function.
1.
Right-click the Clinical Trial Registration Form, select Load File Plan, and click Yes.
This copies the file plan templates to the file plan.
2.
Right-click the file plan for the Clinical Trial Registration Form and select Edit. Add additional
artifacts as needed.
3.
Save the Microsoft Excel Spreadsheet in Microsoft Excel 97-2003 format (.xls format).
4.
Check in the modifications to the repository either to make a new version or to replace the current
version of the Clinical Trial Registration Form.
File Plan Validation
Before activating a file plan, you should validate the file plan to ensure that the entries in the file
plan are correct, consistent, and that required settings are not missing. Validation also updates the
value assistance in the file plan spreadsheet to ensure that country codes, site IDs, and artifact name
lists are correct. If you have recently added country or site registrations to the trial, re-validate the
file plan to make it current.
When validating a file plan, the system records the results in the validation Status column of the
file plan spreadsheet.
File Plans, page 13 provides more information.
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Set Up and Administer Trials
Related topic:
• Validating the File Plan, page 49
Validating the File Plan
1.
Right-click the file plan for the Clinical Trial Registration Form, select Validate, and click Yes.
2.
Right-click the file plan and select Edit. Review the validations on the File Plan worksheet
and make any necessary changes.
3.
Save the Microsoft Excel Spreadsheet in Microsoft Excel 97-2003 format (.xls format).
Check in the modifications to the repository either to make a new version or to replace the current
version of the Clinical Trial Registration Form.
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Set Up and Administer Trials
Adjusting the Trial Schedule
1.
Right-click the Clinical Trial Registration Form and select Adjust Schedule.
2.
In the Clinical Trial Schedule dialog box, review and adjust the trial activation settings including
the Planned Start Dates and the Planned Completion Dates as required.
3.
Click OK.
Trial Schedule Adjustments, page 20 provides information on setting the trial schedule.
Activating the File Plan for a Clinical Trial
Activating the file plan for a clinical trial activates the trial. Activating the trial causes the system to
create placeholders for the artifacts specified in the file plan. The placeholders are in the Required,
Recommended, or Optional lifecycle state depending on the inclusion rule set when creating the file
plan. Each placeholder contains a copy of the relevant template document and has version 0.0. The
version 0.0 indicates that the document is a placeholder. When there is no available content template
for an artifact, the system creates the placeholder as an object without content.
The reconciliation process generates placeholders for missing and repeatable artifacts as needed and
examines the existing placeholders and documents in the TMF folder structure to determine whether
each item is reconciled, redundant, or duplicated:
• Reconciled: A placeholder is considered reconciled if it is non-repeatable and a separate
non-placeholder document exists with the same artifact number, trial ID, country code, and site
ID. In that case, the system automatically deletes the placeholder.
• Redundant: A non-placeholder document is considered redundant if the artifact is designated
as Not Required for the current or preceding stages in the TMF template configuration or is
not referenced at all in any stage.
• Duplicated: A non-placeholder document is considered duplicated if another non-placeholder
document exists with the same trial ID, artifact number, country code, and site ID that was created
before it. They system only counts the first instance in progress reports.
The system continually monitors progress against the file plan. While the trial is active, the current
progress details update automatically by the system on a daily basis. You can also force an update
on demand at any time using the Refresh menu option. The system records progress in the Status
column of the file plan spreadsheet. You can also use the Progress Summary menu option to view the
progress of the trial.
Progress Tracking, page 18 provides additional information.
Related topic:
• Activating the Trial, page 51
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Set Up and Administer Trials
Activating the Trial
1.
Right-click the clinical trial registration form and select Activate.
2.
Click Yes to confirm the trial activation.
The system creates placeholders in the Clinical cabinet as defined in the file plan. The file plan
show a status of Initializing and then changes to Active.
eTMF Folder Structure
EMC Documentum Electronic Trial Master File uses a default folder structure using the zones and
sections as defined by the DIA TMF Reference Model Version 2.0. At each level (Product, Trial,
Country, and Site) the zone and section folders are created.
TMF Structure, page 10 provides detailed information.
When a placeholder document is checked-out, edited, and checked-in, the next version is checked-in
automatically as version 0.1 and is reset to the Draft lifecycle state. The document can then continue
to be edited, reviewed, approved, and made Final, according to its Control Category. Placeholders
can also be deleted and reverted to the initial placeholder version 0.0 by a system administrator.
For Clinical documents, each Control Category 1–3 document that is a TMF artifact should be
preconfigured in the relevant Documentum D2 creation matrix. Control Category 4 documents
should not be used in TMFs.
The default folder structure is:
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Set Up and Administer Trials
Product-level TMF Placeholders and Documents
Product-level TMF placeholders and documents can potentially be shared across multiple trials. If
a product-level placeholder is marked as Not Required in the file plan for a particular trial, or the
file plan entry is removed from the file plan, the system only deletes the placeholder itself if other
trials do not reference it. Likewise, if a trial is reset from Active to Planning, the system deletes all
trial-specific placeholders (at or below the trial level), but product-level placeholders used in that trial
are only deleted if they are not in use in other trials.
The system tracks this by establishing relations (dm_relation links) between the Clinical Trial
Registration Form and the product-level placeholders it uses. This happens automatically when
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Set Up and Administer Trials
the trial activates or refreshes. You can view these relations by selecting an active Clinical Trial
Registration Form and clicking the Relations tab.
Updating the eTMF Structure with Changes
After changing the file plan, you can start the file plan reconciliation process to update the eTMF
folder structure and placeholders.
1.
Right-click the clinical trial registration form that contains the file plan and click Refresh.
2.
In the Confirmation dialog box, click Yes to reprocess the file plan.
The registration form status changes to Refreshing while the update is in progress. The system
adjusts the eTMF structure and placeholders in the Clinical cabinet as defined in the file plan.
When the update is complete, the status changes to Active.
3.
To check the validity of the file plan, right-click the file plan again and click View.
Related topic:
• File Plan Validation, page 48
Viewing Clinical Trial Progress
1.
Log in as a Trial Manager.
2.
To update the trial information, right-click the clinical trial registration form, click Refresh, and
then click Yes.
3.
Right-click the clinical trial registration form and select Progress Summary. The Progress
Summary shows current information about the trial. Progress Tracking, page 18 provides more
information.
Locking a Clinical Trial
Lock a clinical trial to prevent changes to TMF documents after closing the trial.
1.
Log in as a Trial Manager.
2.
In the Repository browser, navigate to the clinical trial registration form that contains the file
plan.
3.
Right-click the file plan and select Lock. Users cannot edit properties or content for the clinical
trial.
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Set Up and Administer Trials
Registration Form Changes that apply to
Existing Documents
When users create documents or the system creates placeholders, the documents and placeholders
inherit attribute values from the registration form. When you change registration form properties,
the changes only apply to new documents or placeholders that are created after the change. For
compliance purposes, this is the default behavior. However, in some situations, it may be necessary
to apply changes to registration form properties down to the existing documents and placeholders.
For example, if you change the product code for a product, the change should affect not just new
documents but also existing documents and placeholders for that product.
Documentum eTMF enables Product Managers and Trial Managers to make the following changes
that apply to existing documents:
• Changing a Product Code for a Product, page 54
• Combining Products, page 55
• Changing Product-related Information for a Product, page 56
• Changing the Therapeutic Area for a Product, page 57
• Changing Clinical Trial Information, page 58
• Moving Trial Documents to a Different Product, page 59
• Changing the Location of a Site, page 59
• Changing the Name of a Site, page 60
These functions are restricted to the registration form managers.
Note: There are no predefined rules governing the conventions for product codes and trial IDs due to
varying customer requirements. Administrators can constrain these fields through regular expression
pattern matching in D2 Config as necessary. For example, Administrators can customize these fields
to alphanumeric only plus certain characters such as underscores, hyphens, and spaces based on their
requirements. The EMC Documentum D2 Administration Guide provides more information.
Changing a Product Code for a Product
Use this procedure to reassign an existing product to a new product code. The change affects not only
the Product Registration Form, but also all of the documents associated with the existing product
code, including historical versions. It also affects the Clinical Trial, Country, and Site Registration
Forms associated with the product.
1.
Log in as a Product Manager.
2.
Right-click a product registration form with a status of In Development or Active and select
Change Product Code.
3.
In the Change Product Code dialog box, type the new product code. Product codes are case
sensitive. For example, if there is already a product code named Emc, the system allows you to
create a product code named emc.
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Set Up and Administer Trials
4.
Select Click Here to Validate. Review the validation result.
5.
To modify the product code, clear the Click here to validate checkbox and repeat from the
previous step.
6.
When you are ready to apply the change, click OK. This procedure updates the related
documents and registration forms to refer to the new product code, including historic versions
of these objects.
Combining Products
Use this procedure to combine the documents and registration forms for product A with another
product B. The relevant documents and registration forms merge with those of product B, and the
system deletes the registration form for product A. This procedure also affects historic versions
of these objects.
Caution: The Combine Product Codes operation is irreversible.
1.
Log in as a Product Manager.
2.
Right-click the product registration form that you want to merge into another product and
select Combine Products. The product registration form must have a status of In Development
or Active.
3.
In the Combine Product Codes dialog box, select the product code to merge with this product.
4.
To combine the product codes, select Click here to confirm the operation.
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5.
When you are ready to apply the change, click OK. To refresh the screen and view the changes,
press F5 or select the Product Library cabinet.
Changing Product-related Information for a Product
As users create product-related documents, the documents and placeholders automatically inherit
product-related metadata from the relevant Product Registration Form, such as Compound IDs,
Trade Names, and Generic Names. Use this procedure to update this product information and apply
the changes to the relevant documents and placeholders.
This procedure affects only current versions of the documents. In order to preserve a record of
the product information that was in force during document creation, the system does not affect
historic versions.
1.
Log in as a Product Manager.
2.
Right-click a product registration form with a status of In Development or Active and select
Update Product Info.
3.
In the Change Product Information dialog box, make the necessary changes and click OK.
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The system applies these settings to the relevant documents and registration forms. This
procedure does not affect historic versions of these objects.
Changing the Therapeutic Area for a Product
Documentum eTMF groups products by therapeutic area to make it easier for users to locate
products. A manager can associate a product with a general therapeutic area initially and then
reclassify it under a different therapeutic area during product development.
Use this procedure to move a product and its associated documents and registration forms to a
new therapeutic area.
1.
Log in as a Product Manager.
2.
Right-click a product registration form with a status of In Development or Active and select
Change Therapeutic Area.
3.
In the Change Therapeutic Area for Product dialog box, select the new therapeutic area and
click OK.
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The system applies these settings to the relevant documents and registration forms, including
historic versions of these objects.
Changing Clinical Trial Information
Similar to changing product information, use this procedure to change trial-related information in
the clinical trial registration form. The system applies these settings to the relevant documents and
placeholders. This procedure does not affect historic document versions.
1.
Log in as a Trial Manager.
2.
Right-click a clinical trial registration form with a status of Planning, Active, or Completed,
and select Update Trial Info.
3.
In the Change Clinical Trial Information dialog box, make the necessary changes and click OK.
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Moving Trial Documents to a Different Product
Use this procedure to move a trial and its associated documents, placeholders, and registration
forms to a different product.
1.
Log in as a Trial Manager.
2.
Right-click a clinical trial registration form with a status of Planning, Active, or Completed, and
select Reassign to Product.
3.
In the Reassign clinical trial documents to a different product dialog box, select the new
therapeutic area and product code.
4.
To reassign the trial to the selected product, select Click here to confirm the operation.
5.
When you are ready to apply the change, click OK. The system applies these settings to the
relevant documents and registration forms. This procedure affects historic versions of these
objects.
Changing the Location of a Site
Use this procedure to associate a site with a different country.
1.
Log in as a Trial Manager or a clinical trial site registration form manager.
2.
Right-click a clinical trial site registration form with a status of Active and select Change Site
Location.
3.
In the Reassign a site to a different country dialog box, select the new country (and state, if
applicable) and click OK.
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The system updates the site-level documents to refer to the new country. The system also
renames site-level TMF documents and placeholders. These updates do not affect historic
versions of these documents.
Changing the Name of a Site
Use this procedure to change the site name, which is the description of the site. It does not change
the internal site code.
1.
Log in as a Trial Manager or a clinical trial site registration form manager.
2.
Right-click a clinical trial site registration form with a status of Active and select Change Site
Name.
3.
In the Rename site dialog box, type the site name and select Click here to validate. Review
the validation result.
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4.
To modify the site name, clear the Click here to validate checkbox.
5.
When you are ready to apply the change, click OK. The system updates the site-level documents
and placeholders to refer to the new site name. The system also renames site-level TMF
documents and placeholders. These updates do not affect historic versions of these documents.
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62
Chapter 4
Import and Index Trial Documents
This section is for Contributors, Authors, Trial Managers, External Contributors, and Investigators
who import and index trial documents.
This section contains the following topics:
• Import and Indexing Process, page 63
• Placeholders, page 65
• Finding a Placeholder, page 65
• Finding a Placeholder using a Public Search, page 65
• Viewing Placeholder Properties, page 66
• Finding a Registration Form, page 66
• Import Documents, page 67
• Indexing a Document in the Finalize Indexing List, page 68
• Indexing a Document in the Document List, page 68
• Finding a Document, page 69
Import and Indexing Process
Importing documents into the Trial Master File (TMF) structure in the Documentum repository
is a two-step process:
• Import: Import documents from your computer into the repository.
• Index: View the document content and compare it with the information in the document
properties. Select and verify the document information and then save the document properties.
After you import the documents, the documents have a status of Index, which means that they are
ready to index. After you index, verify, and save the document information, the status changes to
Final. Documentum eTMF automatically files the documents in the correct location in the TMF
structure based on the indexing selections.
Documentum eTMF uses the following import and indexing process for TMF Documents:
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Import and Index Trial Documents
The following table describes the ways that you can import files:
Import type
Description
Import button on Welcome page
You can import files directly from the Welcome page by
clicking the Import button. Document properties are empty
upon completion of the import.
Import to Placeholder
You can locate a placeholder for a document and then drag
and drop the document onto the placeholder (or select the
placeholder and select Import > File from the menu). The
system automatically populates the document properties with
information from the placeholder.
Import to Registration Form
You can locate a registration form for a document and then
drag and drop the document onto a registration form (or select
the registration form and select Import > File from the menu).
If you have multiple documents of different types associated
to the same product, trial, country, or site, you can import
to a registration form and then index the document-specific
information later. The system automatically populates the
document properties with information from the selected
registration form.
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Import and Index Trial Documents
Placeholders
When a trial activates, the system creates placeholders for the documents specified in the file plan.
There are three types of placeholders:
• Required: Documents must be created for this placeholder. These documents are required and
must be final to complete the eTMF.
• Recommended: Documents should be created for this placeholder and made final to complete the
eTMF. You need to provide a reason to remove this type of placeholder from the eTMF.
• Optional: Documents can be created for this placeholder and made final. These documents are
not required to complete the eTMF.
Placeholders have a version of 0.0. The Status column in the Document List shows the type of
placeholder.
The system automatically removes placeholders as users create or import content for them. If a
placeholder has more than one expected document, the placeholder remains to enable the import
of additional documents. Each document created for a placeholder receives a unique sequence
number, appended to the artifact number.
After receiving the expected number of documents, the system removes the placeholder. If a user
deletes a document, the corresponding placeholder regenerates automatically when the trial is
refreshed.
Finding a Placeholder
1.
Log in as a Contributor or an Investigator.
2.
Click Browse & Search.
3.
Click Find Documents.
4.
In the Choose field, select Find Placeholders.
5.
Select the document Scope (level within the TMF structure), and then select a trial, country, or site.
6.
Click Run. The placeholders appear in the Document list.
Finding a Placeholder using a Public Search
1.
Log in as a Clinical Author, Contributor, Investigator, or Trial Manager.
2.
Click Browse (Author or Trial Manager) or Browse & Search (Contributor or Investigator)
3.
Click Search.
4.
In the Searches > Public Searches folder, double-click the Find Clinical Trial Documents or
Placeholders search query.
5.
In the Choose field, select Find Placeholders.
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Import and Index Trial Documents
6.
In the Query Form dialog box, select the document Scope (level within the TMF structure) and
then select a trial, country, or site.
7.
Click Run.
Viewing Placeholder Properties
The properties of a placeholder provide information on the documents expected and completed
for that placeholder.
1.
In the Document list, right-click a placeholder and select Properties.
2.
On the Classification tab, notice the following placeholder properties as described in the
following table:
Field
Description
TMF Inclusion
Shows the placeholder type.
Number of documents expected
Shows the number of documents expected
for this placeholder. Optional placeholders
have a value of 0 (zero) and you can upload
any number of documents for optional
placeholders.
You can change the expected number of
documents, if necessary.
Number of documents completed
Shows the number of documents that are
current and in the Final state.
Finding a Registration Form
1.
Log in as a Contributor or an Investigator.
2.
Click Browse & Search.
3.
Click Find Registrations.
4.
Select an optional filter or leave the fields blank to find all registration forms.
5.
Click Run.
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Import and Index Trial Documents
Import Documents
This section contains the following topics:
• Importing from the Welcome Page, page 67
• Importing to a Placeholder, page 67
• Importing to a Registration Form, page 67
Importing from the Welcome Page
1.
Log in as a Clinical Author, Contributor, or Investigator.
2.
On the Welcome page, click Import.
3.
On the Select files page, select one or more documents to import from your local file system
and the file format.
4.
Select Same creation profile for all files and click Next.
5.
The uploaded document is ready for indexing and appears on the Import & Index view in the
Finalize Indexing area with a status of Index.
Importing to a Placeholder
1.
In the Document List, select a placeholder.
2.
Drag and drop one or more documents from your computer onto the placeholder. Alternatively,
select Import > File from the menu and select the documents to import by navigating your
file system.
3.
On the Select files page, select the document to import from your local file system and the
file format.
4.
Select Same creation profile for all files and click Next. The file automatically inherits the
relevant properties of the placeholder. The uploaded document is ready for indexing and appears
in the Finalize Indexing area with a status of Index.
Related topic:
• Indexing a Document in the Finalize Indexing List, page 68
Importing to a Registration Form
1.
In the Document List, select a registration form.
2.
Drag and drop one or more documents from your computer onto the registration form.
Alternatively, select Import > File from the menu and select the documents to import by
navigating your file system.
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Import and Index Trial Documents
3.
On the Select files page, select the document to import from your local file system and the
file format.
4.
Select Same creation profile for all files and click Next.
5.
The file automatically inherits the relevant properties of the registration form. The imported
document appears in the Finalize Indexing list. The document has a status of Index, a version of
0.1, and is ready for indexing.
Related topic:
• Indexing a Document in the Finalize Indexing List, page 68
Indexing a Document in the Finalize Indexing
List
1.
In the Finalize Indexing list, select a document.
2.
In the Document Viewer, review the document content.
3.
If you did not select a placeholder before importing the document, do the following:
a.
In Edit Properties, select a scope (level within the TMF structure) and the details required for
the document.
b. In the Name Contains field, start typing the name of the placeholder.
c.
4.
In the Placeholder field, select the placeholder for the document.
Verify the information and click Save. The file is removed from the Finalize Indexing list and the
document status changes to Final.
Indexing a Document in the Document List
1.
In the Document list, locate a document with a status of Index.
2.
To view the document content, right-click the document and select View.
3.
Right-click the document and select Properties.
4.
If you did not select a placeholder before importing the document, do the following:
a.
In the Properties, select a scope (level within the TMF structure) and the details required for
the document.
b. In the Name Contains field, start typing the name of the placeholder.
c.
5.
68
In the Placeholder field, select the placeholder for the document.
Verify the information in the remaining fields and click OK. The document status changes to Final.
Import and Index Trial Documents
Finding a Document
1.
Log in as a Contributor or an Investigator.
2.
Click Browse & Search.
3.
Click Find Documents.
4.
In the Choose field, select Find Documents.
5.
Select the document Scope (level within the TMF structure), and then select a trial, country, or site.
6.
Click Run.
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Import and Index Trial Documents
70
Chapter 5
Create Trial Documents
This section is for Authors, and Trial Managers who create Trial Master File (TMF) documents from
templates.
This section contains the following topics:
• Controlled Documents, page 71
• File Naming and Versioning, page 73
• Omitting a Placeholder, page 74
• Reinstating a Placeholder, page 74
• Document Updates, page 74
• Configuring Content Templates, page 75
• Importing and Exporting Multiple Documents, page 79
Controlled Documents
EMC Documentum Electronic Trial Master File uses placeholders and registration forms to store
clinical trial, country, site, and product information. The documents that you create inherit values
from the placeholders and registration forms and automatically populate the Properties of the
document. There are several methods of inheriting data:
• Inherit data from a TMF placeholder: Import or create a document using a TMF placeholder.
• Inherit data from an existing document: Create a document using a similar document.
• Inherit data from a registration form: Import or create multiple different documents related to a
particular site or trial. Search for or Navigate to a related registration form in the Clinical Trial
Library cabinet and then import or create a document.
The document inherits the initial properties from the selected source. The information from the
selected source appears in the Properties of the document after saving it.
To create or import Clinical or Clinical Trial Master File (TMF) documents, users must be members of
the cd_clinical_doc_authors group.
The following table shows the location of TMF placeholders, clinical documents, and clinical
registration forms in the repository:
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Create Trial Documents
Type
Repository Location
TMF placeholders
Cabinets > Clinical
Clinical documents
Cabinets > Clinical
Clinical trial registration forms
Cabinets > Clinical Trial Library
Related topics:
• Control Categories, page 127
• Clinical User Groups, page 130
This section contains the following topic:
• Creating a Document, page 72
Creating a Document
1.
Log in as a member of the Author group based on the type of document.
2.
From the repository, select a related document or registration form.
3.
Select New > Content from the menu bar.
4.
In the Creation profile field, select a functional area, such as Trial Master File (TMF) Document.
Your role determines the document creation options that appear.
5.
In the Document Type field, select the document to create and click Next.
6.
On the Edit properties page, select or type information in the required fields. Typically, authors
let the system populate the unrequired fields.
If you select or type data in the non-required fields, the new information overrides the values
inherited from the registration forms. In some cases, such as keywords, the system merges the
data. The document properties populate from the selected placeholder or registration form
when you save the document.
7.
Click Next. The document appears in its native format.
8.
From the application, edit the content as needed.
To view the content, refresh the screen. For example, if the native format is Microsoft Word, press
Ctrl-A and then F9 to update the content. The EMC Documentum D2 Administration Guide provides
information on configuring Microsoft Office products to show Documentum D2 properties.
When you are finished, save and close the document.
9.
Click Check In and Finish.
The system creates the document with a minor version number and file name. The document
is checked in. Based on the document type and Control Category, the document is assigned a
lifecycle. The system also stores the document in a directory structure based on the required fields
on the Edit Properties page. When you save the document, information from the product and the
domain registration forms appear in the document Properties and the Advanced Properties.
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Create Trial Documents
Related topics:
• File Naming and Versioning, page 73
• Additional Menu Functions for TMF Documents, page 144
File Naming and Versioning
The document name is automatically assigned based on the naming schema: <artifact
number><artifact name> - <document ID>
Where the artifact number and name are up to 230 characters and the document ID is a 9 digit
incremental number.
For example, when the artifact number and name is 02.01.02 Protocol and the document ID is
000000001, then the name displayed in the D2 Client workspace is: 02.01.02 Protocol - 000000001
Note: For artifacts marked as repeating in the file plan, the system appends a sequence number to
the artifact number to track the different instances of the documents. In the previous example, if the
Protocol artifact was marked as repeatable, the name of the first instance of the document would
be: 02.01.02.01 Protocol - 000000001
When uploading TMF documents, duplicate item numbers are sometimes appended to the artifact
numbers. This is due to the presence of shared (cross-site) documents.
Caution: The system generates the document_id from a 9-digit counter, which allows 100
million unique document IDs. In D2 Config, the size of the counter can be increased by editing
the _Document_ID auto naming configuration. However, the document_id attribute in the
cd_controlled_doc object type is a ten character string. When the digits are increased above
10, the cd_controlled_doc object type must also be changed.
If the counter value on the _Document_ID auto naming configuration is reset after creating
documents, subsequent document IDs might not be unique. Consequently, you should not reset
this counter value in a production repository.
Document versions are minor (v 0.1) until they are made Final. Documents in a Final state have
major version numbers (v 1.0).
The initial version for a placeholder is 0.0. When a placeholder document is checked-out, edited,
and checked-in, the next version is checked-in automatically as version 0.1 and is reset to the Draft
lifecycle state. The document can then continue to be edited, reviewed, approved, and made Final,
according to its Control Category. Placeholders can also be deleted and reverted to the initial
placeholder version 0.0 by a system administrator.
Related topics:
• Placeholders, page 65
• Additional Menu Functions for TMF Placeholders, page 143
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Create Trial Documents
Omitting a Placeholder
To indicate that a Recommended or Required placeholder is no longer needed, you can mark it as
omitted. Users cannot upload documents to a placeholder with a status of Omitted. The trial progress
summary records the number of omitted placeholders and will no longer report the placeholder on
missing document reports.
1.
Right-click a placeholder and select Omit.
2.
For Recommended placeholders, in the Change State dialog box, select the reason for the
omission and click OK.
Related topics:
• Placeholders, page 65
• Additional Menu Functions for TMF Placeholders, page 143
Reinstating a Placeholder
You can reinstate an omitted placeholder to its previous state to allow the addition of content for
the placeholder.
1.
Right-click an omitted placeholder and select Reinstate.
2.
Click Yes to confirm the change.
Document Updates
This section contains the following topics:
• Editing a Document, page 74
• Checking in a Document, page 75
• Sharing a Document across Sites, page 75
Editing a Document
1.
Log in as a member of the Author group based on the type of document.
2.
In the Document list, locate the document.
3.
Right-click the document and select Edit.
4.
Update, save, and close the document.
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Create Trial Documents
Checking in a Document
1.
In the Document list, locate the document.
2.
Right-click the document and select Check in.
3.
The document is checked in and ready to self-approve or add to a workflow.
Related topic:
• Launching the Collaborative Editing Workflow, page 89
Sharing a Document across Sites
You can link a site-level document in the TMF to additional site-level folders or unlink them from the
folders, if necessary.
1.
In the Document list, locate a site-level TMF document.
2.
Right-click the document and select Share across sites.
3.
Select Enable cross-site sharing.
4.
In Other Sites, select the sites to share the TMF document.
5.
Click OK.
Related topic:
• Additional Menu Functions for TMF Documents, page 144
Configuring Content Templates
When a user creates a document, the content for the new document is based on a content template.
Depending on the document that the user creates, Documentum eTMF automatically selects one or
more appropriate content templates.
Managers can create or modify content templates. The artifacts (document types) that Managers
assign to a content template control the templates that appear to users when creating a document.
Administrators can add new templates to Documentum eTMF using standard D2 Config functionality
described in the EMC Documentum D2 Administration Guide. EMC Documentum Electronic Trial
Master File offers an alternative method of creating content templates in D2 Client.
When configuring document templates, review www.Adobe.com for information on the fonts that
appear correctly in PDFs. The fonts used must be available on the client machines and the Rendition
Server. The Rendition Server embeds the fonts into the PDF. When Adobe Acrobat cannot find the
fonts specified in the content template, it generates a message that warns the user that it is using
alternative fonts in the PDF version. This problem can cause information loss or reformatting
issues. Avoid these issues by using fonts that are compatible with Adobe Acrobat. Use D2 Client to
perform these procedures.
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Create Trial Documents
Topics in this section include:
• Creating a Content Template, page 76
• Modifying a Content Template, page 77
Creating a Content Template
1.
Log in as a member of one of the manager groups (for example, cd_clinical_trial_managers).
2.
Select New > Content from the menu bar.
3.
On the Fill creation profile page:
a.
In the Creation profile field, select the management profile or domain. To create a content
template for a Trial Master File (TMF) document, select Clinical Trial Management for eTMF.
b. In the Document Type field, select the content template type. To create a content template for
a TMF document, select Clinical Content Templates.
c.
4.
Click Next.
On the Edit properties page:
a.
Type a name for the template in the Name field.
b. In the Applicable Artifacts area, select artifacts (document types) to use for the template
from the List Assistance dialog box, and click OK.
When a user creates a document type specified in this content template, this content
template appears as a selection on the Choose Template page. For example, if you select the
Accountability Documentation artifact, this content template appears when users create
that document type.
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Create Trial Documents
c.
Click Next. The content template appears in the Templates/D2 folder.
5.
Select your content template and then select Import > New version from the menu bar.
6.
In the Import dialog box, select a template file to import and click OK.
7.
In the Checkin dialog box, select a version for the template and click OK.
Modifying a Content Template
You can modify a content template and the artifacts associated with the template. The artifacts
that you assign to the content template control the templates that appear to users when creating a
document.
1.
Log in as a member of one of the manager groups.
2.
In the Repository browser, navigate to the Templates/D2 folder.
3.
Right-click the content template and select Edit to adjust the template in its native format.
4.
Exit, save, and check in the template.
5.
To adjust the applicable artifacts, right-click the content template and select Properties.
6.
In the Properties dialog box, adjust the selected applicable artifacts.
Include an artifact (document type) if you want this content template available for users creating
that document type. Remove an artifact if you do not want this content template available to users
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Create Trial Documents
creating that document type. For example, if you remove the Accountability Documentation
artifact, this content template no longer appears to authors who create this type of document.
7.
78
Click OK to update the content template properties.
Create Trial Documents
Importing and Exporting Multiple Documents
EMC Documentum Electronic Trial Master File uses document packages to import and export Trial
Master File (TMF) placeholders, documents, and associated document information (metadata).
Clinical Trial Managers create a document package in the repository and zip the package to export
it to the local file system. The ZIP file contains a Contents folder that contains documents and an
Index.xls Microsoft Excel spreadsheet that contains metadata. Trial managers can electronically send
the package to a recipient who can work on the documents and metadata on their own computer,
without connecting to the TMF system.
The recipient can unzip the document package, view the document package contents, and open
the Index.xls spreadsheet. The recipient can use the spreadsheet to add documents from their file
system or to modify the content files in the package. They can also update the metadata in the
Microsoft Excel spreadsheet.
The Index.xls file, also known as the bulk import-export spreadsheet, is not the same as a TMF file
plan spreadsheet. The following figure shows an example bulk import-export spreadsheet:
Users populate the File List worksheet with information about the documents they want to import.
The File List worksheet contains the metadata for each document. It contains references to either the
contents of the document package or to local file names if they are adding files to the package.
The Schema worksheet defines the form and content of the spreadsheet. This information is
preconfigured for system use. The values in the drop-down lists on the File List worksheet come
from the schema.
After updating the document package, the recipient zips the modified document package for import
into the repository. The document package, also known as the TMF bulk import-export package,
imports into the repository as a new version of the package. When importing multiple documents
using the bulk import-export spreadsheet, the system only imports and updates changed files.
Complete the following procedures to create document packages, export them to the local file system
for modifications, and then import them back into the repository:
• Creating a TMF Bulk Import-Export Package for a Trial, page 80
• Zip and Export the TMF Bulk Import-Export Package, page 81
• Populating the Bulk Import-Export Spreadsheet, page 83
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Create Trial Documents
• Importing the Document Package ZIP File, page 85
• Starting the Bulk Import of Documents, page 85
Creating a TMF Bulk Import-Export Package for a Trial
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
In the Clinical Trial Library cabinet of the Repository browser, select a clinical trial registration
form and then select New > Content from the menu bar.
3.
In the Creation profile field, select Clinical Trial Management for eTMF.
4.
In the Document Type field, select Bulk Import / Export Package and click Next.
5.
Configure the TMF bulk import-export package properties as described in the following table:
Field
Description
Package Name
Type the name of the bulk import-export task.
Description
Type a description of the TMF bulk import-export package.
Therapeutic Area
Select the therapeutic area used for product grouping.
Product Name
Select the product name (for example, compound name)
associated with the clinical trial.
Clinical Trial ID
Select the unique ID for the clinical trial.
Study Phase
Shows the study phase for the selected clinical trial.
Study Name
Shows the study name for the selected clinical trial.
The Therapeutic Area, Product Name, and Clinical Trial ID automatically populate as defined in
the registration form.
6.
Click Next. The system files the bulk import-export spreadsheet in the Document Packages
subfolder below the clinical trial registration form and sets the status to New.
7.
Zip and export the TMF bulk import-export package for offline review and updates. Zip and
Export the TMF Bulk Import-Export Package, page 81 provides more information.
The ZIP operation automatically refreshes the value assistance for the bulk import-export
spreadsheet. To update and view the value assistance before zipping the package, you can refresh
the spreadsheet. Refreshing the Value Assistance for the Bulk Import-Export Spreadsheet, page
81 provides more information.
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Create Trial Documents
Refreshing the Value Assistance for the Bulk
Import-Export Spreadsheet
The bulk import-export spreadsheet contains a Schema worksheet that controls many of the fields
and labels on the File List worksheet. Some of the fields on the Schema worksheet populate based
on characteristics of the trial. For example, the registered countries and sites for a trial populate the
Schema worksheet so that a user can select these values on the File List worksheet. If you register a
new site with the trial, refresh the value assistance for the Schema worksheet to add the new values.
1.
In the Repository browser, navigate to your bulk import-export spreadsheet.
2.
Right-click the spreadsheet and select Refresh.
3.
Click Yes to confirm the drop-down list updates.
Zip and Export the TMF Bulk Import-Export Package
After creating a document package, you can specify the documents and placeholders to include in the
package. The system creates a ZIP file that contains metadata and any content files for the selected
documents and placeholders.
1.
In the Document Packages folder, right-click the TMF bulk import-export package and select Zip.
2.
Configure the TMF bulk import-export package contents as described in the following table:
Field
Description
Include in the package
Select whether to include placeholders, documents, or both
in the package.
File Format
Select whether to include PDF renditions, native content
files, or both in the package.
Scope
Select whether to include all documents (artifacts); product
and trial-level documents; country and site documents for a
specific country; or site-specific documents.
Sites
If you select site-specific documents, select the sites to
include in the package.
Countries
If you select country and site documents, select the
countries to include in the package.
From Date
To filter the documents in the package by creation date,
select a date range. Leave the date fields blank if you do not
want to filter by creation date.
To Date
To select documents created since a particular date, select a
From Date but not a To Date.
If you click a date field and press Delete to clear it, press the
Tab key to refresh the Number of items field.
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Create Trial Documents
Field
Description
Number of items
Shows the number of items in the package. If the number
of items is 0, you cannot create a package.
Allow other document types to
be added
Enables users to include other reference model document
types in the package. Clear this option to restrict the
document types to those document types defined in the
package.
3.
Click OK. The TMF bulk import-export package status changes to Zipped. To refresh the package
status, click the Document Packages folder in the repository.
4.
To check the status of the zipped package, right-click the package and select Properties. The
package properties show the results of the last operation.
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If necessary, you can rezip an invalid package by selecting it and repeating this procedure using
different selection criteria. You do not have to create another package.
5.
To export the zipped TMF bulk import-export package:
a.
Select the zipped package and select Content > Export from the menu bar.
b. Select a folder on the local file system to export the zipped package.
6.
Unzip the contents of the zipped TMF bulk import-export package to a clean folder on the local
file system. The Documentum metadata file extracts into a Microsoft Excel spreadsheet named
Index.xls. The content files and PDF renditions extract into the Contents subfolder. If your
package includes only placeholders, the zip file only contains the Index.xls file.
7.
Edit the Index.xls file (bulk import-export spreadsheet) to add and modify content files and
update associated metadata. If necessary, you can attach the zipped package to an email and
send it to another user.
Related topic:
• Populating the Bulk Import-Export Spreadsheet, page 83
Populating the Bulk Import-Export Spreadsheet
1.
In the Microsoft Excel bulk import-export spreadsheet, click the Enable Content button to enable
the macros.
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2.
On the File List worksheet, specify the documents and metadata to add or modify as described in
the following table:
Column
Description
Filename
To select a content file, double-click an empty cell in the
Filename column. The system automatically copies the file
to the Contents subfolder and points to that file. If there is
a file with the same name in the Contents subfolder, the
system renames the file with a unique name.
This field is blank for placeholders until you add content.
To edit an included file, click a hyperlink to open the file
and then modify and save the file. After importing and
unzipping the file, the system detects the changes in the file.
Artifact Name
Select the document type.
Item number
Use this column to import multiple documents for
repeatable artifacts. Repeatable artifacts can have more
than one document. You can insert multiple rows into the
spreadsheet and number the documents in sequence from 1.
If you leave this column blank or set it to 0 (zero) and
the artifact is repeatable, the system creates a document
and assigns the next item number in sequence to it
automatically. If the artifact is not repeatable, it creates a
new version of the document if a document exists.
Scope
Select the location of the document in the Trial Master File.
Country (where applicable)
For country-level documents, select the country. This
field is optional for site-level documents. For product or
trial-level documents, leave this field blank.
Site (where applicable)
For site-specific documents, select the site; otherwise, leave
this field blank.
Document Title
Type the document name.
Keywords
Type keywords for the document. Type multiple values as
a comma-separated value list such as 1,2,3.
Status
Type the lifecycle state of the imported document. For
example, you can type Final or Effective to import the
document as Final or Effective versions.
If you leave this field blank, the Unzip operation uploads
the new content files as Draft documents by default.
Hover your cursor over the column heading cells to view additional information.
3.
84
To help identify the documents or placeholders, you can view the read-only fields highlighted in
light blue. The read-only fields include Version, Validity, and the Repository Path of the imported
or exported item. The Validity column shows any validation errors.
Create Trial Documents
4.
Do not update the Schema worksheet. The system automatically updates the schema. The
information in the drop-down lists on the File List worksheet comes from the schema.
5.
Save the Microsoft Excel Spreadsheet in Microsoft Excel 97-2003 format (.xls format).
6.
If the bulk import-export package is on your local file system:
a.
Delete the original ZIP file package.
b. Recreate the ZIP file package using the following structure:
• <package_name>.zip
— Index.xls (This file is the updated bulk import-export spreadsheet)
— Contents (This subfolder contains all of the content files for import or export.)
— artifact.doc
— artifact2.pdf
c.
Import the TMF bulk import-export package ZIP file. Importing the Document Package ZIP
File, page 85 provides more information.
Importing the Document Package ZIP File
After zipping a document package, you can import an updated version of that package into the
system to update the objects in the package. For example, you can create a document package ZIP file
for a specific site that contains all of the placeholders. You can send the ZIP file to the site monitor
who can update the bulk import-export spreadsheet and add documents to the placeholders. The site
monitor can then send you an updated ZIP file to import into the system.
1.
Log in as a member of the cd_clinical_trial_managers group.
2.
In the Document Packages folder, select the zipped TMF bulk import-export package to update.
3.
Select Import > New Version from the menu bar.
4.
Select the TMF bulk import-export ZIP file on your local file system and click OK. The status still
shows as Zipped since it contains a ZIP file.
5.
Click the Versions tab to verify the new document package version.
6.
Process the TMF bulk import-export ZIP file in the repository. Starting the Bulk Import of
Documents, page 85 provides more information.
Starting the Bulk Import of Documents
After you import an updated ZIP file into the document package, the system processes it when a trial
manager or other user with the appropriate permissions performs an unzip operation. The Unzip
uses the information in the bulk-import spreadsheet to update the object metadata and content.
1.
In the Repository browser, right-click the TMF bulk import-export ZIP file and select Unzip.
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Create Trial Documents
2.
Specify how to extract the TMF bulk import-export package ZIP file contents as described in
the following table:
Field
Description
Extract
Select whether to extract all documents (artifacts); product
and trial-level documents; country-specific documents; or
site-specific documents.
Including unplanned content
Select whether to enable the import of unplanned
documents. Unplanned documents do not have
corresponding placeholders in the repository.
Select this option to import unplanned content and create
TMF documents in the repository.
Clear this option to import only planned content in the
repository.
3.
Click OK. The status changes from Unzipping to Unzipped.
If the import is successful, the contents of the TMF bulk import-export package ZIP file import
into the repository in the location specified by the bulk import-export spreadsheet. The status
of the package changes to Unzipped. Right-click the package and select Properties to view the
package status. You can also open the unzipped bulk import-export spreadsheet and check the
Validity column to verify that the affected rows processed correctly.
If the import is unsuccessful, the status changes to Invalid. If the package status is invalid,
right-click the package and select Properties to view the error message. Manually correct the
package, check it in as a new version, and reprocess the package.
4.
86
Navigate to the Clinical cabinet to view the files created from the ZIP file.
Chapter 6
Review and Approve Trial Documents
This section is for Authors, Document Coordinators, Reviewers, Approvers, and Trial Managers who
participate in the review and approval of Trial Master File (TMF) documents.
This section contains the following topics:
• Workflow Process, page 87
• Document Review and Approval, page 88
• Performing Tasks in a Workflow, page 90
• Processing Documents in a Workflow, page 93
• Working with Final Documents, page 96
• Viewing Document Status, page 98
• Viewing Workflow Progress, page 98
• Workflow Task Performer Changes, page 99
Workflow Process
A workflow is a series of tasks that users perform on documents. Tasks appear in their inboxes with
documents and instructions on how to complete the tasks. For example, an author starts a workflow
by sending a document to one or more reviewers using a review workflow. When the workflow starts,
the system automatically sends the document to the specified reviewers to perform a review task.
Each reviewer receives a review task. When a reviewer finishes a task, it goes to the next performer or
finishes. The workflow creates separate tasks for each user participating in the workflow.
There are two main types of workflow users:
• Workflow task performers: These users complete tasks in a workflow.
• Workflow supervisors: These users originate the document and start the workflow. Workflow
supervisors are usually Authors or Document Coordinators. Authors can act as document
coordinators on Trial Master File (TMF) documents.
Documentum eTMF uses the following workflows for TMF documents:
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Review and Approve Trial Documents
Workflow
Description
Collaborative Editing
Sends a document to a group of Reviewers for initial feedback
or collaborative authoring. The Reviewers coauthor the
document and edit the document at the same time. Authors
can incorporate the changes into the document and make
additional revisions.
Review
Sends a document for review. If you select multiple Reviewers,
the workflow sends the documents to all of them at the same
time.
A Reviewer can approve the document by accepting the task
or annotate the document and send it back to the Author.
The Author receives a task to either finalize the document or
to revise it and send it back to the Reviewer.
Authors generally use these workflows one after the other. Authors initially send documents for
collaborative editing. After incorporating the changes in the document, they can send the document
to other Reviewers before they finalize it.
The following figure illustrates the typical order of the Documentum eTMF workflows:
In addition to using workflows that involve other Reviewers, Authors can self-approve and finalize
TMF documents directly by changing the lifecycle state of the document to Final.
Document Review and Approval
This section contains the following topics:
• Launching the Collaborative Editing Workflow, page 89
• Launching the Review Workflow, page 89
• Self-approving a Document, page 90
88
Review and Approve Trial Documents
Launching the Collaborative Editing Workflow
1.
Log in as a member of an Author or Document Coordinator group.
2.
Right-click a document and select Send to workflow > For collaborative editing.
3.
In the Planning / Sending of Workflow dialog box:
a.
On the Recipients tab, verify the participant group fields. Modify the recipients as needed.
b. Click Notifications to type information about the document. The participants of the workflow
review the Workflow notes as the document completes task processing.
c.
Click Attachments to add additional content required for processing workflow tasks.
d. Click Planning and Follow-up to select a date for planning and following up on the task in
the workflow.
4.
Click Send to send the document to the specified user in the workflow.
Related topics:
• Collaborative Editing, page 93
• For Collaborative Editing, page 149
Launching the Review Workflow
1.
Log in as a member of an Author or Document Coordinator group.
2.
Right-click a document and select Send to workflow > Submit for Review.
3.
In the Planning / Sending of Workflow dialog box:
a.
On the Recipients tab, verify the participant group fields. Modify the recipients as needed.
b. Click Notifications to type information about the document. The participants of the workflow
review the Workflow notes as the document completes task processing.
c.
Click Attachments to add additional content required for processing workflow tasks.
d. Click Planning and Follow-up to select a date for planning and following up on the task in
the workflow.
4.
Click Send to send the document to the specified participant in the workflow.
Related topics:
• Reviewing Documents in a Review Task, page 94
• Reviewing Document Feedback from Reviewers, page 95
• Approving Documents, page 96
• Submit Document for Review, page 150
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Review and Approve Trial Documents
Self-approving a Document
1.
In the Document list, right-click a document and select Self-approve and make Final.
2.
Click OK.
Performing Tasks in a Workflow
As documents progress in an Documentum eTMF workflow, users are assigned tasks based on their
role. For example, Reviewers perform reviewing tasks and Approvers perform approving tasks.
EMC Documentum Electronic Trial Master File provides defined groups for each role.
In the workflows for controlled documents, task participants have five days to perform a task.
Tasks participants receive messages in their Tasks inbox to remind them that a task requires
attention. Administrators can modify the default settings in D2 Config. The EMC Documentum D2
Administration Guide provides configuration information. By default, messages are sent:
• When a workflow task participant does not perform the task in three days, a message notifies
the task participant that they have two days to complete the task. Tasks that are not complete
within two days are rejected. A message is also sent to the workflow initiator (usually the Author)
that the task is not complete.
• When there are 0 days left, the system sends a final message to the task participants informing the
workflow initiator that the task will be rejected.
The following actions are standard workflow actions for processing tasks in EMC Documentum D2:
• Acquire Task: Confirms that the task has been read and received.
• Accept Task: Confirms that the task has been completed and its quality accepted.
• Reject Task: Confirms that the task is completed or its quality was not acceptable.
• Abort workflow: Closes the workflow. Administrators and workflow supervisors can perform
this task.
The EMC Documentum D2 User Guide provides additional information on performing standard
Documentum D2 tasks in a workflow.
Related topics:
• User Roles, page 25
• Viewing the Audit Trail, page 90
• Categorizing Inbox Tasks, page 91
Viewing the Audit Trail
EMC Documentum Electronic Trial Master File audits events for controlled documents. The system
does not audit events for non-controlled documents.
1.
90
Click the Tasks button to open the tasks view.
Review and Approve Trial Documents
2.
To view the audit trail for a task, navigate to the Workflow task list, select a task, and then
click the Audit tab.
3.
To view the audit trail for a document, select a document and click the Audit tab.
4.
To export report information in a read-only, portable format, right-click the Audit tab and select
Export to Excel.
Categorizing Inbox Tasks
Follow this procedure to categorize inbox tasks.
1.
Click the Tasks button.
2.
Click the down arrow on the Workflow task list tab and select Switch widget.
3.
Select the Tasks browser widget. The tasks in the inbox appear in different categories.
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Review and Approve Trial Documents
4.
In another area, add the Workflow task list widget. For example, click the + tab (Add widget)
next to the Task Attachment tab and select the Workflow task list widget.
5.
In the Tasks browser, click a category to see the tasks in Workflow tasks list tab.
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Processing Documents in a Workflow
The following topics describe how to process documents in a workflow:
• Collaborative Editing, page 93
• Editing a Document in a Workflow, page 93
• Incorporating Document Changes, page 94
• Reviewing Documents in a Review Task, page 94
• Reviewing Document Feedback from Reviewers, page 95
• Approving Documents, page 96
Collaborative Editing
In the Collaborative Editing workflow, Authors and Reviewers edit documents in the Edit document
task. The Author originating the document incorporates the changes into the document from the
Reviewer feedback. When the Collaborative Editing workflow finishes, add the document to the
Review workflow.
Follow these procedures to edit documents:
• Editing a Document in a Workflow, page 93
• Incorporating Document Changes, page 94
Related topic:
• For Collaborative Editing, page 149
Editing a Document in a Workflow
1.
Depending on the workflow, log in as a member of an Author or Reviewer group.
2.
In the Workflow task list, select the task.
3.
In Task Attachment, select the document and then select Content > Native annotations from
the menu bar.
Note: D2 supports adding and editing annotations only in the Microsoft Word native format.
The annotations functionality does not work for other formats such as Microsoft Excel, Microsoft
PowerPoint, and so on. See the EMC Documentum D2 User Guide for more information about
annotations.
4.
Edit the document in its native format and save the changes.
The EMC Documentum D2 Administration Guide provides information on configuring Microsoft
Office products to show Documentum D2 properties.
5.
Click Relations, right-click the document with annotations, and select Check in.
6.
In the Workflow task list, right-click the task, select Accept task, add a comment, and click OK.
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When the task is accepted, the document routes to Authors in the Incorporate changes task.
Incorporating Document Changes
1.
Log in as a member of an Author group.
2.
Click the Tasks button to open the tasks view.
3.
In the Workflow task list, select the task.
4.
In Task Attachment, select the document and then select Content > Edit with native annotations
from the menu bar.
5.
Edit the document in its native format, accept or reject the changes, and save the document.
6.
Right-click the document, and select Check in.
7.
Right-click the task and select Accept task.
8.
In the Task dialog box, select one of the options:
• Select Finish the editing workflow to complete the task.
• Select Return the document to the Reviewers to continue editing the document.
9.
Click OK.
10. If the document can be self-approved, right-click the document, select Self-approve and make
Final, and click OK. If this option is not available, the document must be formally-reviewed and
approved before it becomes Final.
Reviewing Documents in a Review Task
In the Review tasks of the TMF document review workflow, Reviewers review documents.
The Author that originates the document reviews the feedback received from the Reviewers in a
separate workflow task.
1.
Log in as a member of a Reviewer group.
2.
Click the Tasks button to open the tasks view.
3.
In the Workflow task list, select the task.
4.
Select the document from the Task Attachment area.
5.
To review and annotate the PDF document format:
a.
In the Task Attachment area, double-click the document and annotate the PDF.
b. When you finish reviewing the document, save and close it.
c.
6.
94
To check in the annotations, click Relations, right-click the document with annotations,
and select Check in.
To annotate the document in its native format, for example, in Microsoft Word:
Review and Approve Trial Documents
a.
In the Task Attachment area, select the document and then select Content > Native
annotations from the menu bar.
b. Edit the document in its native format and save the changes.
The EMC Documentum D2 Administration Guide provides information on configuring
Microsoft Office products to show Documentum D2 properties.
c.
To check in the annotations, click Relations, right-click the document with annotations,
and select Check in.
7.
In the Workflow task list, right-click the task and select Accept task.
8.
Select one of the following options:
• Change to Reviewed: This option approves the document and it proceeds to the Ready to
be Made Final task.
• Change to Draft: This option rejects the document and returns it to the Author as a Draft task.
9.
Add a comment, and click OK. The task is accepted and proceeds to the next task.
Related topic:
• Reviewing Document Feedback from Reviewers, page 95
• Submit Document for Review, page 150
Reviewing Document Feedback from Reviewers
When the Reviewers return a document to the Author (document originator) for further changes, the
Author receives a task to review the document. The document reverts to the Draft state. The Author
reviews and merges the comments and annotations from the Reviewers.
1.
Log in as a member of an Author group.
2.
Click the Tasks button to open the tasks view.
3.
In the Workflow task list, select the task.
4.
In the Task Attachment area, double-click the document to view any PDF annotations.
5.
To merge native annotations from the Reviewers (for example, tracked changes in Microsoft
Word):
a.
In the Task Attachment area, select the document and then select Content > Edit with native
annotations from the menu bar.
b. Merge comments by accepting or refusing the modifications.
c.
Save and close the document.
d. Right-click the document and select Check in.
6.
Right-click the task and select one of the following options:
• Select Accept task to route the document back to the Approver or Reviewer.
• Select Reject task to complete the workflow. You can add the document to another workflow,
such as the Collaborative editing workflow for additional editing.
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Review and Approve Trial Documents
Approving Documents
1.
Log in as a member of an Author for the TMF document Review workflow.
2.
Click the Tasks button to open the tasks view.
3.
In the Workflow task list, select the task.
4.
To review the document, in the Task Attachment area, double-click the document to view it
in PDF format.
5.
When you finish reviewing the document, right-click the task and select one of the following
options:
• Select Accept task to approve the document and prepare to make the document final. The
workflow completes and the document state changes to Reviewed. In the Document List,
right-click the document, select Self-approve and make Final, and click OK. The document
state changes to Final and the document is now approved for use.
• Select Abort workflow to stop the workflow. The document returns to the Draft state. You
can add the document to another workflow, such as the Review workflow to send it to
additional Reviewers.
Working with Final Documents
This section contains the following topics:
• Suspending a Document, page 96
• Withdrawing a Document, page 96
• Deleting Documents Permanently, page 97
• Superseded Documents, page 97
Suspending a Document
Suspending a Final document prevents it from being used while a modified version is being
prepared, reviewed, and approved.
1.
In the Document list, right-click a document in the Final state and select Suspend document.
2.
Click OK.
3.
To reinstate the document, select Reinstate as Final version.
Withdrawing a Document
You can retire documents in the Draft, Release Pending, or Final states by withdrawing them. All
versions are withdrawn together. You can retain Withdrawn documents as historical records.
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Review and Approve Trial Documents
Document Coordinators or any user with sufficient access rights can permanently remove Withdrawn
documents from the system using Hard Delete.
1.
In the Document list, right-click a document and select Withdraw document.
2.
Click OK.
3.
To reinstate a withdrawn document, select Revert to Draft.
Deleting Documents Permanently
Clinical Document Coordinators or any user with sufficient access rights can permanently delete
documents from the system using Hard Delete. When users perform a Hard Delete of a document,
Documentum eTMF audits the event. You can search for these events in the audit trail. For example,
Clinical Document Coordinators can use this feature to delete trial documents permanently at the end
of the trial retention period.
Caution: It is not possible to recover hard deleted documents.
1.
In the Document list, select one or more documents in the Withdrawn state. If you have a
Withdrawn tab, you can select the tab and then select one or more documents from within the tab.
2.
Right-click the documents and select Hard Delete.
3.
Type or select a reason for removing the documents permanently and click OK. The system
deletes only the selected version of the document. Documentum eTMF audits the hard delete
action for each document deleted under the event name cdf_hard_delete. If you select multiple
documents, the system applies the same reason to the audit event for each document.
If the administrator configures the system to delete related documents, the system deletes both
documents. The system records only the dm_destroy event (not the cdf_hard_delete event)
for the related document.
You can view hard deleted documents using the Find Delete Audit Events search query.
Related topic:
• Chapter 8, Find Documents
Superseded Documents
Superseded documents are documents that were previously Final. There is only one Final version
of a document at a time. The system automatically updates the document state when new Final
versions are created. For example:
1.
Version 0.1: Process a document in a Review / Approval workflow.
2.
Version 1.0: Document Coordinators change the document state to Final. The version is 1.0.
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Review and Approve Trial Documents
3.
Version 1.1: The document is edited and in a Draft state.
4.
Version 2.0: Document Coordinators change the document state to Final. The updated Final
document is version 2.0. The original document, which was version 1.0, is now automatically
changed to Superseded.
Viewing Document Status
Users can view the progress of a document in the document properties.
1.
In the Document list, locate the document.
2.
Right-click the document and select Properties.
3.
On the Process Info tab, you can view the control category of the document and its status.
4.
Click Cancel.
Viewing Workflow Progress
Authors and Document Coordinators can monitor the progress of document workflow tasks.
1.
Log in as a member of a Document Coordinator or Author group.
2.
Select a document in the Document list and click Workflow overview.
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Review and Approve Trial Documents
3.
Expand the workflow to view the workflow tasks. Active workflows and tasks show a Running
state.
Workflow Task Performer Changes
After a workflow starts, it is often necessary to change the performer of a workflow task. For example,
a reviewer may not be available to complete a review inbox task. In this case, the reviewer can
delegate the task to another workflow task performer.
Workflow task performers can delegate the tasks in their inboxes to other workflow task performers.
Workflow supervisors can change the workflow task performers in the following ways:
• Delegate a task that is in the inbox of any workflow task performer. For example, a workflow
supervisor can delegate a task because an employee left the company or is out of the office on
sick leave. You can delegate only the tasks that are in the inbox of workflow task performers,
not future tasks.
• Stop a workflow and send a document to a new workflow to add additional performers to a
current task. For example, a workflow supervisor sends a document to the Review workflow and
the workflow creates a task for Reviewer 1. The workflow supervisor can stop the workflow and
then resend the document for review to Reviewers 1, 2, and 3.
There are two sets of performers for a document. One set is the performers defined on the Process
Info tab of the document properties. The other set is the performers that actually participate in the
workflow. When a workflow starts, the workflow task performers are set based on the performers
listed on the Process Info tab. Any change in the workflow performers using the Update performers,
Send to workflow, or Reassign Roles menu options changes only the actual workflow performers. It
does not change the performers shown on the Process Info tab. These workflow performers have
access to the documents only when they are the current performers, that is, they have a task in
their inbox.
Updating Workflow Task Performers
1.
Log in as a workflow supervisor.
2.
Navigate to the document for which you are updating performers.
3.
In the Document list, select the document and click Workflow overview.
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Review and Approve Trial Documents
If you do not have a Workflow overview tab, click the + tab and select the Workflow overview
widget.
4.
In the Workflow overview, right-click a workflow with a state of Running and select Update
performers.
5.
Update the performers as needed and click OK.
Performers of all current activities as well as future activities can be modified other than
Document Coordinator. Document Coordinator can be updated only for the future activities.
Stopping a Workflow
1.
Log in as a workflow supervisor.
2.
Navigate to the document for which you want to stop the workflow.
3.
In the Document list, select the document and click Workflow overview.
4.
In the Workflow overview, right-click the workflow you want to stop and select Abort workflow.
5.
Click OK. The workflow state changes from Running to Aborted.
Delegating a Task as a Workflow Supervisor
1.
Log in as a workflow supervisor.
2.
Navigate to the document for which you are delegating a task.
3.
In the Document list, select the document and click Workflow overview.
If you do not have a Workflow overview tab, click the + tab and select the Workflow overview
widget.
4.
100
In the Workflow overview, expand the workflow, right-click the user whose task you want to
delegate, and select Delegate task.
Review and Approve Trial Documents
5.
In the From the user field, select the user whose task you want to delegate.
6.
In the To the user field, select the user to receive the task and click OK.
Delegating a Task as a User
All workflow users can delegate their tasks to another workflow performer.
1.
In the Workflow task list, locate a task to delegate.
2.
Right-click the task and select Delegate task.
3.
In the User field, select the user to receive the task and click OK.
Reassigning Roles
1.
Log in as a member of a Document Coordinator or Author group. Authors and document
coordinators can reassign roles for TMF documents.
2.
Right-click a document and select Reassign Roles. Change the user groups assigned to the roles
as needed. Each tab represents a different user role. For example, on the Approvers tab, you
can replace the approvers listed for that role.
3.
Click OK.
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Review and Approve Trial Documents
102
Chapter 7
Inspect a Trial
This section is for Inspectors and internal Clinical Auditors, who audit clinical trials.
This section contains the following topics:
• Locating Documents, page 103
• Viewing Documents and their Properties, page 104
• Viewing Documents Side-by-side, page 104
• Adding Notes, page 104
• Viewing and Deleting Notes, page 104
• Viewing the Document History, page 104
• Export the Document List to Microsoft Excel, page 104
Locating Documents
The eTMF view shows folders and documents associated with the trials, countries, and sites to which
you have access. The folder structure is based on the Drug Industry Association (DIA) reference
model zones and sections within each level (trial, country, or site). When you select a folder in
Browse, the documents within that folder appear in the Document list.
You can search for documents by product (compound), clinical trial, country, site, and document
type. You can perform ad hoc searches by typing text to locate documents. For example, if you
type Principal, the search returns all documents containing Principal. You can export your search
results lists to Microsoft Excel.
Finding Documents
1.
Click Find Documents.
2.
Select the document Scope (level within the TMF structure), and then select a trial, country, or site.
3.
Click Run.
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Inspect a Trial
Viewing Documents and their Properties
1.
Select a document in the Document list to view it in the Document Viewer. If the PDF viewer of
your browser allows printing, you can print the document directly from the Document Viewer.
2.
To view the document properties, click the Properties tab next to the Document Viewer.
Viewing Documents Side-by-side
The Concurrent View enables you to view the content of two documents at the same time.
1.
Right-click a document and select View in Viewer 1.
2.
Right-click another document and select View in Viewer 2.
Adding Notes
1.
Right-click a document or a folder and select Add note.
2.
Type a comment and click Post.
Viewing and Deleting Notes
1.
To view a note, select a document and click the Notes tab.
2.
To delete a note, mouse over the note and click Delete.
Viewing the Document History
The document history, also known as the audit trail, shows information on what has happened
to the document. It includes lifecycle state changes, such as changing from Index (Draft) to Final
(Effective) and any document property value changes.
1.
Click the eTMF button and select a document.
2.
Click the Audit tab. The audit trail shows relevant information for the selected document.
Export the Document List to Microsoft Excel
You can export the list of files in the Document list to a Microsoft Excel spreadsheet.
1.
104
Right-click the Document list tab and select Export to Excel.
Inspect a Trial
2.
Select a location for the file on your local file system.
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Inspect a Trial
106
Chapter 8
Find Documents
Field settings on the Classification tab in the Properties dialog box determine the folders in which the
solution stores documents. Because the directory structure is multi-layered, use the Documentum D2
advanced search methods described in the EMC Documentum D2 User Guide or the searches that are
specific to Documentum eTMF to find documents. You can find the queries specific to Documentum
eTMF in the Searches > Public Searches folder.
EMC Documentum Electronic Trial Master File also provides an optional reporting feature for
monitoring active clinical trials based on the Euroscript Documentum Report Generator (eDRG).
These reports only appear if they are included in the solution. The Chapter 9, View Trial Master File
Reports section provides information on the reports.
The following table describes the Documentum eTMF search queries:
Query name
Applicable roles for
viewing the report
Description
Find Clinical Trial Documents
or Placeholders
Clinical
Contributors,
Authors, and
Coordinators
Finds TMF documents, including
placeholders. Can be restricted to specific
countries, sites, or artifact names.
Trial Managers
Find Clinical Trial Documents
with Document Filters
Clinical
Contributors,
Authors,
Coordinators,
Reviewers, and
Approvers
Finds TMF documents. Can be restricted
to specific countries, sites, or artifact
names.
Readers, and
Auditors
Trial Managers
107
Find Documents
Query name
Applicable roles for
viewing the report
Description
Find Registration Forms
Contributors,
Authors, and
Coordinators
Finds all registration forms including
product, trial, country, and site registration
forms.
Trial Managers
External
Contributors and
Investigators
Find Clinical Trials by Name,
ID, or Product Code
Clinical
Contributors,
Authors, and
Coordinators
Finds clinical trial registration forms.
A summary of the status and current
progress of each matching trial is shown.
Reviewers and
Approvers
Readers
Trial Managers
Find Clinical Trials by Product
Clinical
Contributors,
Authors, and
Coordinators
Finds clinical trial registration forms based
on a selected product.
Reviewers and
Approvers
Readers
Trial Managers
Find Clinical Trials by
Therapeutic Area
Clinical
Contributors,
Authors, and
Coordinators
Reviewers and
Approvers
Readers
Trial Managers
108
Finds clinical trials registration forms
based on a selected therapeutic area.
Find Documents
Query name
Applicable roles for
viewing the report
Description
Find Delete Audit Events
Clinical Authors
and Coordinators
Provides a list that includes withdrawn
and/or hard deleted documents
for a specified date range. Hard
deleted documents show the
event name cdf_hard_delete, while
withdrawn documents list the
d2_change_state_success event.
Trial Managers
For cdf_hard_delete event entries, Value1
shows Hard-Deleted and Value2 shows
the previous status of the document before
being hard deleted. Values 3, 4 and 5
show the audited attribute values of the
document in pairs of two each, if your
Administrator configured them in theTMF
Doc Delete Config - Attributes to Audit
list.
Deleting Documents Permanently, page 97
provides more information.
Find Effective / Final
Documents by Domain
Contributors,
Authors,
Coordinators,
Reviewers, and
Approvers
Finds documents in a Final lifecycle state
based on the domain of the document
(for example, Procedure, Clinical,
Non-Clinical, Quality, and Regulatory)
and an optional keyword.
Readers
Clinical Auditors
Trial Managers
Find Effective / Final
Documents
Contributors,
Authors,
Coordinators,
Reviewers, and
Approvers
Finds documents in a Final lifecycle state
based on a specified product and an
optional therapeutic area and keyword.
Readers
Trial Managers
Find My Clinical Trial
Documents
Clinical
Contributors,
Authors, and
Coordinators
Searches for TMF documents authored or
coordinated by the user.
Trial Managers
109
Find Documents
Query name
Applicable roles for
viewing the report
Description
Find My Documents
Contributors,
Authors, and
Coordinators
Finds documents in which the current user
is an Author or Document Coordinator.
Users can specify a keyword to filter
the results. Only Authors or Document
Coordinators can run this query and find
documents.
Trial Managers
Find Outstanding Task
Participants
Authors and
Coordinators
Trial Managers
Finds users that have not completed a
task on a document that is currently in a
workflow.
Product Managers
Find Products
Contributors,
Authors,
Coordinators,
Reviewers, and
Approvers
Searches for product registrations.
Readers
Trial Managers
Find Sites for a Trial
Contributors,
Authors,
Coordinators,
Reviewers, and
Approvers
Lists the site registrations for a particular
trial.
Readers
Trial Managers
Show Current Workflow
Progress
Authors and
Coordinators
Trial Managers
110
Shows a list of workflow tasks for all
running workflows for the selected
document.
Chapter 9
View Trial Master File Reports
EMC Documentum Electronic Trial Master File provides optional reports to monitor active clinical
trials based on the Euroscript Documentum Report Generator (eDRG). The reports only appear if
your organization includes them in the solution. Clinical Trial Managers and Document Coordinators
can access the reports in the Dashboard.
You can configure your own additional reports using the Euroscript Documentum Report Generator.
The eDRG documentation provides more information.
This section contains the following topics:
• Overview of the TMF Reports, page 111
• Viewing Dashboard Reports, page 112
• Product - Trials Table, page 114
• Product - Trials by Status, page 115
• Trial - Missing Documents Table, page 117
• Trial - Missing Documents by Zone, page 118
Trial - Missing Documents by Status, page 119
• Trial - Full Inventory Table, page 120
• Trial - Received Documents by Status, page 121
• Trial - Progress History, page 122
• Trial - Schedule Status by Stage, page 123
• Trial - Site Status, page 124
• Site - Full Inventory Table, page 125
Overview of the TMF Reports
The following table provides a brief description of each of the reports which are installed out
of the box:
111
View Trial Master File Reports
Report
Description
Product - Trials Table
Shows an overview of the trials for a selected
product.
Product - Trials by Status
Shows a status summary of all trials for a selected
product.
Trial - Missing Documents Table
Shows missing documents (placeholders) for a
selected trial.
Trial - Missing Documents by Zone
Shows the number of missing documents by zone.
Trial - Missing Documents by Status
Shows the number of missing documents by status
(Required, Recommended, and Optional).
Trial - Full Inventory Table
Shows the documents and placeholders for a
selected trial by zone, section, artifact number, and
status. This report includes product, trial, country,
and site-level documents for the selected trial.
Trial - Received Documents by Status
Shows the number of received documents for a
selected trial by status.
Trial - Progress History
Shows the progress history for each stage of the
selected trial on a timeline.
Trial - Schedule Status by Stage
Shows the schedule progress of each stage for the
selected trial.
Trial - Site Status
Shows the status of each site for the selected trial.
Site - Full Inventory Table
Shows the site-level documents and placeholders
for a selected site.
Related topic:
• Viewing Dashboard Reports, page 112
Viewing Dashboard Reports
1.
Log in as a member of the cd_clinical_trial_managers or cd_clinical_doc_coordinators group.
2.
Click Dashboard.
3.
Select a Clinical Trial, Site, or Product Registration form for an active clinical trial. The reports
available depend upon the registration form you select as shown in the following table:
Registration Form
Available Reports
Product Registration Form
• Product - Trials Table
• Product - Trials by Status
112
View Trial Master File Reports
Registration Form
Available Reports
Clinical Trial Registration Form
• Trial - Missing Documents Table
• Trial - Missing Documents by Zone
• Trial - Missing Documents by Status
• Trial - Full Inventory Table
• Trial - Received Documents by Status
• Trial - Progress History
• Trial - Schedule Status by Stage
• Trial - Site Status
Site Registration Form
4.
• Site - Full Inventory Table
In the Dashboard reports area, select a report. For example, if you select a Clinical Trial
Registration Form, you can select Trial - Missing Documents by Zone as shown in the following
figure:
113
View Trial Master File Reports
Product - Trials Table
The Product - Trials Table report shows an overview of the trials for the product you select. For each
trial, it shows the current stage, a list of sites, and planned and actual start and end dates. When you
click a row, it shows additional information about the planned stages for the selected trial.
Select a Product Registration Form to view this report.
The following figure shows an example Product - Trials Table dashboard report:
114
View Trial Master File Reports
Product - Trials by Status
The Product - Trials by Status report shows a status summary of all trials for the product you select.
The pie chart summarizes the percentage of trials in each state (Active, Completed, and Planning).
Hover your cursor over the pie chart to show additional information.
Select a Product Registration Form to view this report.
An optional table shows a trial summary that includes the trial name, current progress, and condition
codes. The following condition codes appear in the report:
• White: Inactive
• Green: On track
• Amber: Close to limits (slight risk)
• Red: Behind schedule (serious risk)
The following figure shows an example Product - Trials by Status dashboard report:
115
View Trial Master File Reports
116
View Trial Master File Reports
Trial - Missing Documents Table
The Trial - Missing Documents Table shows missing documents (placeholders) for the trial you select.
It shows the name, scope, and status for each placeholder. The placeholders link to Documentum
eTMF.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Missing Documents Table dashboard report:
117
View Trial Master File Reports
Trial - Missing Documents by Zone
The Trial - Missing Documents by Zone report shows the number of missing documents by zone.
Hover you cursor over the pie chart to show additional information such as the percentage of missing
documents by zone.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Missing Documents by Zone dashboard report:
118
View Trial Master File Reports
Trial - Missing Documents by Status
The Trial - Missing Documents by Status report shows the number of missing documents by status
(Required, Recommended, and Optional). Hover your cursor over the bar chart to show additional
information. If Optional documents appear, they show 0 (zero) missing documents because Optional
documents are not considered missing.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Missing Documents by Status dashboard report:
119
View Trial Master File Reports
Trial - Full Inventory Table
The Trial - Full Inventory Table report shows the documents and placeholders for the selected trial by
zone, section, artifact number, and status. This report includes product, trial, country, and site-level
documents for the selected trial. The documents link to Documentum eTMF.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Full Inventory Table dashboard report:
120
View Trial Master File Reports
Trial - Received Documents by Status
The Trial - Received Documents by Status report shows the number of received documents for a
selected trial by status. For example, status can include Draft, In Review, For Approval, and Final.
Hover your cursor over the bar chart to show additional information.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Received Documents by Status dashboard report:
121
View Trial Master File Reports
Trial - Progress History
The Trial - Progress History report shows the progress history for each stage of the selected trial on a
timeline. Hover your cursor over the line chart to show additional information on the selected stage.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Progress History dashboard report:
122
View Trial Master File Reports
Trial - Schedule Status by Stage
The Trial - Schedule Status by Stage report shows the schedule progress of each stage for the trial
you select. The bars reflect the completion percentage. Hover your cursor over the bar chart to
show additional information. An optional table provides additional information about the stages
(planned and actual start and end dates).
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Schedule Status by Stage dashboard report:
123
View Trial Master File Reports
Trial - Site Status
The Trial - Site Status dashboard shows the status of each site for the trial you select. The bars reflect
the completion percentage.
Select a Clinical Trial Registration Form to view this report.
The following figure shows an example Trial - Site Status dashboard report:
124
View Trial Master File Reports
Site - Full Inventory Table
The Site - Full Inventory Table report shows the site-level documents and placeholders for the site
you select. It shows the documents by zone, section, and artifact number. The documents link to
Documentum eTMF.
Select a Site Registration Form to view this report.
The following figure shows an example Site - Full Inventory Table dashboard report:
125
View Trial Master File Reports
126
Chapter 10
Document Control
EMC Documentum Electronic Trial Master File uses control categories in association with lifecycles,
user roles, and permissions to control documents and metadata.
This section contains the following topics:
• Control Categories, page 127
• Documentum eTMF User Groups, page 128
• External Trial Participant Roles, page 130
• Document Lifecycle Model, page 134
• Registration Form Lifecycle Models, page 137
• Additional Menu Functions, page 142
• Permissions, page 145
Control Categories
The Life Sciences solution provides four category levels to secure documents as the documents
progress through their lifecycle. The control categories are assigned internally by the solution based
on the document type. End users typically do not need to be aware of a document’s control category.
The control categories and associated user roles and lifecycle states control which users can access the
document. Control Categories 1–3 documents proceed through defined controlled lifecycles; Control
Category 4 documents have a defined lifecycle that is not controlled.
The common security features for all control categories:
• Allow joint and collaborative authoring in Documentum D2.
• Restrict access to content based on user role and lifecycle state.
• Allow complete withdrawal of the document with optional retention of historic copies.
The following table describes the security of the document control categories:
127
Document Control
Control Categories
Security Description
Category 1
Controlled documents that require formal
review and approval along with 4-eyes
approval and electronic signoff by the Quality
Organization (QO).
Category 2
Controlled documents that require formal
review and approval. They require electronic
signoff, but the signature does not have to come
from the Quality Organization.
Category 3
Controlled documents that can be self-approved
by Authors. Independent review and approval
is optional.
By default, most TMF artifacts are classified as
Category 3.
Category 4
Non-controlled general documents that do
not require formal review or approval. These
documents are not allowed in regulatory
submissions and are not part of the TMF.
Authors manage access to these documents.
The following table shows the user roles and document lifecycle states associated with TMF
(Category 3) documents:
User Roles
Contributor
Authors
Reviewers
Auditors
Readers
Lifecycle States
Index
Draft
For Review
Reviewed
Final
Suspended
Superseded
Withdrawn
Documentum eTMF User Groups
In addition to providing defined user roles, EMC Documentum Electronic Trial Master File includes
these defined user groups:
• Cross-functional User Groups, page 129
• Reporting Groups, page 129
• Clinical User Groups, page 130
128
Document Control
Related topics
• User Roles, page 25
• External Trial Participant Roles, page 130
• External Trial Participant Groups, page 131
Cross-functional User Groups
The following table describes the cross-functional user groups:
Groups
Description
cd_admingroup
Administrator:
• Access to administrative functions
• Require Administrative client capability
• Do not have access to controlled documents
cd_product_managers
Product managers who create Product
Registration Forms.
cd_general_doc_authors
Users in the role can create general documents
(letter, memos, notes). By default, all
other authors groups are members of the
cd_general_doc_authors role.
Reporting Groups
EMC Documentum Electronic Trial Master File provides an optional reporting feature for monitoring
active clinical trials based on the Euroscript Documentum Report Generator (eDRG). The reports
can be customized using the Euroscript Documentum Report Generator (eDRG). The eDRG
documentation provides more information.
In Documentum D2, users view dashboards containing report information. The following table
describes the reporting groups used by the Report Generator:
Groups
Description
report_user
Report Users can generate reports and view
historical data in the form of saved reports.
report_builder
Report Builders can manage report definitions
and presentations.
report_administrator
Report Administrators can define categories and
scheduling of reports.
129
Document Control
Clinical User Groups
Use the clinical user groups for clinical and clinical trial documents. The following table describes the
clinical user groups:
Groups
Description
cd_clinical
Contains all of the other cd_clinical_* groups as
members. So if a user is in one of the groups
in this table, they are automatically part of this
group. Users should not be added directly to
cd_clinical.
cd_clinical_doc_approvers
Clinical document approvers
cd_clinical_doc_auditors
Clinical document auditors
cd_clinical_doc_authors
Clinical document authors
cd_clinical_doc_contributors
Clinical document contributors who import
files to a Trial Master File (TMF), but unlike
authors, they do not author new documents
from templates in the system.
cd_clinical_doc_readers
Clinical document readers
cd_clinical_doc_reviewers
Clinical document reviewers
cd_clinical_trial_managers
Clinical trial managers who create Clinical Trial,
Country, and Site Registration Forms.
External Trial Participant Roles
Documentum eTMF enables you to add a named user to participate as a particular role within the
eTMF system. These users, known as external participants, can receive access to a countries or
sites. External participants only have access to the documents associated with the entity granted.
Administrators specify document access levels when configuring the user roles. The EMC
Documentum for Life Sciences Installation Guide provides more information. External trial participants
require a Documentum user account (dm_user) for system access.
Note: The use of the term external does not require the user to be a contractor or otherwise external to
the system. It means that they do not have global access to all documents in the system and only have
access to what managers specifically grant to them.
Managers can register external participants for countries and sites to grant access for the specified
entities. They register the external participants by adding them to the relevant site or country
registration forms. By default, users who have Write access to the registration form can add external
trial participants. The Access Control tab of a registration form defines the users who can update the
form. For example, a clinical trial manager or a local site administrator delegated to act in this role
can add external participants to registration forms. These participants receive the access specified in
the registration form.
The following table describes the default external participant roles:
130
Document Control
Role
Description
Investigator
A clinical investigator responsible for
administering the drug or therapy to subjects
(patients or volunteers) and recording clinical
data on each subject.
Inspector
A representative of the health authority or
regulatory agency responsible for ensuring that
good clinical practice is followed during the
conduct of the trial.
External Contributor
A producer of specific documents or a person
who can typically import eTMF documents.
For example, a member of a Contract Research
Organization.
External Reviewer
A peer reviewer or participant of specific
documents. For example, an expert in the
relevant field of medicine.
Related topics:
• External Trial Participant Groups, page 131
• External Trial Participant Registrations, page 39
• Security Considerations for Internal and External Users, page 40
• Giving Access to External Trial Participants, page 41
• Verifying External Trial Participant Access, page 42
External Trial Participant Groups
The system creates user groups for providing document access to external trial participants. The
following table describes the external trial participant user groups:
Groups
Description
tmf_global_external_participants
Provides access rights common to all external
participants. This group is a Trial Master File
(tmf) group.
tmf_contributors
Provides read-only and browse access to the
top-level Clinical cabinet and therapeutic area
folders. All clinical trial participants belong to
this group indirectly.
tmf_external_contributors
Assigns a workspace to the External
Contributors.
tmf_external_reviewers
Assigns a workspace to the External Reviewers.
tmf_inspectors
Assigns a workspace to the Inspectors.
tmf_investigators
Assigns a workspace to the Investigators.
131
Document Control
Groups
Description
pg_<product-code>
Provides Read access to the product-level
folders.
(Product group)
tg_<trial-ID>
(Trial group)
cg_<trial-ID>_<country-code>
(Country group)
sg_<site-ID>
(Site group)
Provides Read access to the top-level TMF folder
for the trial.
Provides Read access to the top-level country
folder for the trial.
Provides Read access to the top-level site folder
for the trial.
Each external trial participant user group is further divided into subgroups for roles with the
following suffixes:
• Investigator: _inv
• Inspector: _insp
• External Contributor: _contrib
• External Reviewer: _rev
For example, for Product XYZ, Trial 1234, Country cc, and Site ccnnnnnn, the system creates the
following groups and subgroups:
• pg_XYZ
— PG_XYZ_inv
— PG_XYZ_insp
— PG_XYZ_contrib
— PG_XYZ_rev
• tg_1234
— tg_1234_inv
— tg_1234_insp
— tg_1234_contrib
— tg_1234_rev
• cg_1234_cc
— cg_1234_cc_inv
— cg_1234_cc_insp
132
Document Control
— cg_1234_cc_contrib
— tcg_1234_cc_rev
• sg_ccnnnnnn
— sg_ccnnnnnn_inv
— sg_ccnnnnnn_insp
— sg_ccnnnnnn_contrib
— sg_ccnnnnnn_rev
Note: You should not directly add users to these groups. The system automatically populates these
groups when you select Manage External Participants.
Related topic:
• External Trial Participant Registrations, page 39
133
Document Control
Document Lifecycle Model
This section describes the state transitions for TMF documents.
• Trial Master File Document Lifecycle States, page 134
• Trial Master File Document Lifecycle, page 135
Trial Master File Document Lifecycle States
The following table describes the TMF document lifecycle states:
State
Description
Index
Indicates imported documents that are ready for indexing.
Draft
Indicates created documents or check-in document versions.
Documents in a workflow can revert to a Draft state for
additional editing.
For Review
Indicates documents submitted for review by Reviewers.
Reviewed
Indicates that the review phase is complete.
Final
Indicates documents that are approved for use and current.
They have a major version number. Readers can view the Final
version of documents.
Suspended
Indicates a Final document that was changed to Suspended by
an Author or a Document Coordinator. This state prevents the
document from being used while a modified version is being
prepared, reviewed, and approved. Suspended documents can
be reinstated to Final if necessary, or they will be changed to
Superseded when the next version or replacement document
becomes Final. Alternatively, the entire document tree can be
Withdrawn.
Superseded
Indicates a previously-Final version of a document that
was replaced by a more recent version that was Reviewed,
Approved, and made Final. Superseded versions are, by
definition, out-of-date. However, retention is necessary for
compliance purposes.
134
Document Control
State
Description
Withdrawn
Indicates retired documents. All versions are withdrawn
together. Document Coordinators can withdraw a document
at any time, which affects all versions. Users are not allowed
to create new versions of a Withdrawn document. However, it
can be reverted to Draft if necessary, to enable its content to be
reused or deleted. Retain Withdrawn documents as historical
records.
Clinical Document Coordinators or any user with sufficient
access rights can permanently remove Withdrawn documents
from the system using Hard Delete.
Deleting Documents Permanently, page 97 provides more
information.
Required
Indicates a placeholder document that must be created and
made Final in order for the eTMF to be considered as complete.
Recommended
Indicates a placeholder document that should be created and
made Final in order for the eTMF to be considered as complete.
A reason is required to remove this type of document from the
eTMF.
Optional
Indicates a placeholder document that can be created and made
Final, but is not required for a eTMF to be complete.
Omitted
Indicates an artifact that has been removed from the eTMF
by Document Coordinators or Authors. This operation is not
allowed for Required placeholders unless they are designated
as repeatable artifacts and at least one other instance of that
artifact exists. Omitted documents are maintained and can be
reinstated using the Lifecycle menu.
Trial Master File Document Lifecycle
The following figure illustrates the lifecycle state transitions in the Trial Master File (Control Category
3) Documents Lifecycle Model:
135
Document Control
136
Document Control
Registration Form Lifecycle Models
The lifecycles of the registration forms indicate the status of a particular product, trial, or project
document.
Documents referring to a product code cannot be made Final while the registration form is in the
Suspended or Withdrawn state.
When a Trial Registration Forms is set to Suspended or Completed, documents associated with that
trial cannot be made Final. This provides control for Clinical Trial Managers and ensures that the
current set of Final documents is not modifiable while the trial registration is in these states.
Temporary suspension of a trial may be necessary on occasion if the trial is the subject of a
Serious Adverse Event (SAE) investigation or audit. However, this does not necessarily prevent
work-in-progress documents related to the trial from being created, reviewed, and approved in the
meantime. When the trial registration is reactivated, the additional documents can then be made Final.
• Product Registration Form Lifecycle, page 137
• Clinical Trial Registration Form Lifecycle, page 139
• Clinical Trial Country Registration Form Lifecycle, page 140
• Clinical Trial Site Registration Form Lifecycle, page 141
Product Registration Form Lifecycle
Documents referring to this product code cannot be made Final while the Product Registration
Form is in the Suspended or Withdrawn states.
The following figure illustrates the lifecycle state transitions in the Product Registration Form
Lifecycle Model:
137
Document Control
The following table describes the lifecycle states in the Product Registration Form Lifecycle Model:
State
Description
In Development
Indicates a product that has not been marketed yet. Registration
Form is in initial entry.
Active
Indicates a product that has been approved for use in at least one
country by the relevant authorities and is actively being marketed
in that country. Registration form is in an active state. Documents
can be processed and made final.
Suspended
Indicates a product that was suspended from the market for some
reason, such as a Serious Adverse Event (SAE) report that is being
investigated or a manufacturing issue. Registration Form is in
a frozen state. Documents relating to the product can still be
prepared, but cannot be made Final: Consequently, the current set
of Final documents is protected from further changes.
Withdrawn
Indicates a product that has been withdrawn from the market,
such as a product that has was superseded by a generic equivalent
following patent expiration.
138
Document Control
Clinical Trial Registration Form Lifecycle
Documents referring to this trial registration cannot be made Final while the Trial Registration Form
is in the Suspended, Completed, or Locked states.
Trial Registration Form Lifecycle Model, page 21 provides detailed information.
The following figure illustrates the lifecycle state transitions in the Clinical Trial Registration Form
Lifecycle Model (Trial Registration Form Lifecycle Model):
The following table describes the lifecycle states in the Clinical Trial Registration Form Lifecycle
Model:
State
Description
Active
Indicates a trial has been planned and activated by the trial
manager. Documents can be processed and made final.
139
Document Control
State
Description
Completed
Indicates a trial or project that has finished (no longer active).
Planning
This is the initial lifecycle state for a Clinical Trial Registration
Form. While the registration form is in this state, the Trial
Managers can enable TMF file planning and pre-configure the file
plan templates using the Trial Planning lifecycle menu function.
When ready, they use the Activate lifecycle menu function to
activate the trial, which prompts the user to confirm or adjust the
planned start dates, end dates, and slack periods, then launches
the template reconciliation process.
Initializing
Indicates a transient state that the TMF template construction
process is running in the background.
Suspended
Indicates a trial that was suspended for some reason, such as a
Serious Adverse Event (SAE) report that is being investigated
or a manufacturing issue. Registration Form is in a frozen state.
Documents relating to the trial can still be prepared, but cannot
be made Final. Consequently, the current set of Final documents
is protected from further changes.
Locked
Locks a clinical trial to prevent changes to and uploading of TMF
documents.
Clinical Trial Country Registration Form Lifecycle
Documents referring to this country code cannot be made Final while the Clinical Trial Country
Registration Form is in the Inactive state.
The following figure illustrates the lifecycle state transitions in the Clinical Trial Country Registration
Form Lifecycle Model:
140
Document Control
The following table describes the lifecycle states in the Clinical Trial Country Registration Form
Lifecycle Model:
State
Description
Active
Indicates a country has sites which are participating in the trial.
The registration form is in an active state. Documents can be
processed and made final.
Inactive
A frozen state, documents relating to the country can still be
prepared, but cannot be made Final. The current set of Final
documents is protected from further changes.
Clinical Trial Site Registration Form Lifecycle
Documents referring to this site code cannot be made Final while the Clinical Trial Site Registration
Form is in the Inactive state.
The following figure illustrates the lifecycle state transitions in the Clinical Trial Site Registration
Form Lifecycle Model:
The following table describes the lifecycle states in the Clinical Trial Site Registration Form Lifecycle
Model:
State
Description
Active
Indicates a site is participating in a trial. The registration form is
in an active state. Documents can be processed and made final.
Inactive
A frozen state, documents relating to the site can still be prepared,
but cannot be made Final. The current set of Final documents is
protected from further changes.
141
Document Control
Additional Menu Functions
In addition to the standard Documentum D2 menu functions (Checkout, Edit, Check in, Cancel
Checkout, and so on) and the lifecycle state transition functions described in the Lifecycles section,
the following additional menu functions are available. These functions do not change the status
of the selected object.
• Additional Menu Functions for Trial Registration Forms, page 142
• Additional Menu Functions for TMF Placeholders, page 143
• Additional Menu Functions for TMF Documents, page 144
Additional Menu Functions for Trial Registration Forms
These menu functions apply to Trial Registration Forms only and are restricted to the designated Trial
Managers. These menu functions require end-user confirmation.
The following table describes the Trial Registration Form menu functions:
Trial Registration Form
menu function
Description
Load / Reload File Plan
Generates the default file plan based on the file plan templates associated
with the relevant Product, Country, and Site Registration Forms,
including the file plan template for the Trial Registration Form. (Trial
Registration Form Lifecycle Model) provides additional information.
Validate
Validates the current file plan, but does not activate it. The Validate
function applies to Trial Registration Forms in the Planning state. To use
this function, the Trial Registration Form must have a file plan defined
for it in Microsoft Excel 97-2003 format (.xls format) stored as the main
content file in Documentum. File plans do not support Microsoft Excel
2007 and 2010 format (.xlsx format). You can use Microsoft Excel 2007
or 2010 to view, edit, and save file plan spreadsheets, but you must
save them as Microsoft Excel 97-2003 files before checking them into
Documentum.
After validating the file plan, the system records the validation results
in the Validity column of the file plan spreadsheet. You can review the
validation results by opening the Trial Registration Form content file
in Microsoft Excel.
Progress Summary
142
Provides a summary of the overall progress for the trial for all stages
up to and including the current active stage, plus a breakdown of the
progress of each stage, including the start and end dates. If the trial
is time constrained, the specified planned start and end dates appear
along with the overall risk condition code (Green, Amber, or Red). The
Progress Summary function applies to Trial Registration Forms that are
in the Active or Completed states.
Document Control
Trial Registration Form
menu function
Description
Adjust Schedule
Enables you to verify and adjust the schedule. You can specify the
number of planned stages, the auto-activation and rollover options,
the activation limit (product, trial, country, or site level), and whether
the trial is time constrained. If the trial is time constrained, you can
also specify the planned start and end dates for each stage. The Adjust
Schedule function applies to Trial Registration Forms that are in the
Planning or Active states.
Rollover to Next Stage
Enables you to activate the next stage, regardless of whether the
current stage or preceding stages are incomplete. This function creates
additional placeholders for the artifacts planned for the next stage.
The overall level of progress may suddenly diminish as a result. The
Rollover to Next Stage function applies to Active trials with more than
one stage, where the stages activate in sequence and the currently active
stage is not the last stage.
Update Trial Info
Enables you to change trial-related information in the clinical trial
registration form. The system updates the relevant documents. The
Update Trial Info function applies to Trial Registration Forms that are
in the Planning, Active, or Completed states.
Reassign to Product
Enables you to move a trial and its associated documents and
registration forms to a different product. The system also applies these
changes to historic versions of the objects. The Reassign to Product
function applies to Trial Registration Forms that are in the Planning,
Active, or Completed states.
Additional Menu Functions for TMF Placeholders
These menu functions apply to TMF placeholders, but not documents.
The following table describes the TMF placeholder menu functions:
TMF Placeholder menu
function
Description
Import / File*
Enables a content file upload from the local file system. If you do not
select anything in the browser, you must fill in all of the details on
the Classification page so that the system knows which artifact (TMF
document type) to create, where to file it, and how it to name it. If you
preselect a placeholder or existing TMF document in the browser, it
automatically inherits the relevant properties from the selected item and
it is not necessary to fill in the information.
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Document Control
TMF Placeholder menu
function
Description
Import / New Version*
Enables a content file upload from the local file system for the selected
placeholder. If the selected placeholder is for a repeatable artifact, the
system creates the file as a separate document beside the placeholder
with the next item number in the sequence starting from .01. The same
placeholder is available to upload additional documents. Otherwise, the
system creates the file as a new version of the placeholder. In both cases,
the status of the new document or version resets to Draft.
Omit
Enables you to mark a placeholder as Omitted if you do not intend to
provide a corresponding document or set of documents for it. The
selected placeholder must be in the Recommended or Optional state.
You cannot mark Required placeholders as omitted and documents are
required. For Recommended placeholders, you must specify the reason
for the omission. A reason is not necessary for Optional placeholders.
Reinstate
Enables a placeholder that is currently marked as Omitted to revert to its
previous state (Recommended or Optional) so that you can provide a
document or set of documents for it.
Properties
Enables you to modify placeholder properties if you have the
appropriate permissions. For example, expected and actual document
count, TMF zone, section, artifact number, and artifact name. You can
only modify the expected document count for a TMF placeholder if the
placeholder is for a repeatable artifact.
*The Import function is available on the menu bar.
You can import files using drag and drop. Drag the file from the local file system and drop it into
the Documentum D2 Browser widget (the tree view panel). It does not matter where you drop
the file because it auto-files in the appropriate folder. You can preselect a placeholder or existing
document in the browser before using drag and drop and the document inherits the relevant
properties automatically.
Additional Menu Functions for TMF Documents
These menu functions apply to TMF documents, but not placeholders.
The following table describes the TMF document menu functions:
TMF Document menu
function
Description
Purge interim versions
Removes all historic versions of the document that are in the Draft state,
For Review, For Approval, or Withdrawn state. It does not remove
the current version. This function is available with the selection of the
current version and is restricted to the Document Coordinators and
Authors of the document.
144
Document Control
TMF Document menu
function
Description
Share across sites
Enables you to link a site-level document to additional site-level folders
or unlink them from those folders, if necessary. The selected document
must be a site-level document in the TMF.
Reassign roles
Enables users to adjust the current role settings for all future performers.
For TMF (Control Category 3) documents, the user must be either an
Author or Document Coordinator. The system audits role changes.
Adjust Effective /
Review / Expiry dates
Enables users to modify the effective (final) date, review date, and expiry
date settings for the selected document. For Control Category 1 and 2
documents, the user must be a Document Coordinator in order to use
this function. This option is not available for Category 3 TMF documents.
Properties
Enables you to modify basic properties of the selected document if you
have the appropriate permissions. For example, title, TMF zone, section,
artifact number, artifact name, and keywords.
Advanced Properties
Enables you to modify the full properties of the selected document if you
have the appropriate permissions. In addition to the basic properties,
you can modify the inherited trial and product information, process
information, role settings, and other document-specific information such
as current state, version number, last modifier, and modify date.
You can also configure sharing across sites as an alternative to using the
Share across sites function.
The system audits any changes to document role settings.
Hard Delete
Enables a Clinical Document Coordinator or any user with sufficient
access rights to remove documents permanently from the system. For
example, a trial reaches the end of its retention period and the Clinical
Document Coordinator permanently removes those trial documents
from the system. Only documents in the Withdrawn lifecycle state can
be hard deleted. The user must provide a reason for every document
that they hard delete. When hard deleting multiple files, one reason
can cover all of them.
Caution: It is not possible to recover hard deleted documents.
Permissions
EMC Documentum Electronic Trial Master File configures the permissions of documents based on
the user role and the document category. Permissions are defined for each item in the repository.
Permissions identify the security level needed for a group or user to access the item and their
allowed actions.
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Document Control
The basic permissions in Documentum D2 are:
• NONE: Cannot access any object or object attributes.
• BROWSE: Can view the properties of the object.
• READ: Can view the properties of the object and content.
• RELATE: Same as READ, plus users can add object annotations.
• VERSION: Same as RELATE, plus users can change object content.
• WRITE: Same as VERSION, plus users can alter attributes and change content without updating
the version.
• DELETE: Same as WRITE, plus users can delete any object.
The EMC Documentum D2 User Guide provides additional information on permissions.
The following topics describe the permissions that are available in EMC Documentum Electronic
Trial Master File:
• Trial Master File Document Permissions, page 146
• Product Registration Form Permissions, page 147
• Clinical Trial Registration Form Permissions, page 147
• Country and Site Registration Form Permissions, page 148
Trial Master File Document Permissions
The Documentum eTMF permissions for TMF documents (Control Category 3) are listed in the
following table for the contributors, authors, document coordinators, and reviewers roles:
State
Contributors
Authors
Document
Coordinators
Reviewers
Index
DELETE
DELETE
WRITE
WRITE
Draft
DELETE
DELETE
WRITE
WRITE
Reviewed
(Cat 3 only)
VERSION
VERSION
READ
READ
Final
VERSION
VERSION
READ
READ
Superseded
VERSION
VERSION
READ
READ
Suspended
VERSION
VERSION
READ
READ
Withdrawn
READ
READ
READ
READ
Required
WRITE
WRITE
WRITE
NONE
Recommended
WRITE
WRITE
WRITE
NONE
Omitted
WRITE
WRITE
WRITE
NONE
The Documentum eTMF permissions for TMFdocuments (Control Category 3) are listed in the
following table for the readers and auditor roles:
146
Document Control
State
Readers
Auditors
Index
NONE
NONE
Draft
NONE
NONE
Reviewed
(Cat 3 only)
NONE
NONE
Final
READ
READ
Superseded
NONE
READ
Suspended
NONE
READ
Withdrawn
NONE
NONE
Required
NONE
NONE
Recommended
NONE
NONE
Omitted
NONE
NONE
Product Registration Form Permissions
The permissions for Product Registration Forms are listed in the following table:
State
Managers
User Groups
Default
In Development
DELETE
RELATE
NONE
Active
DELETE
RELATE
NONE
Suspended
DELETE
RELATE
NONE
Withdrawn
DELETE
RELATE
NONE
Clinical Trial Registration Form Permissions
The permissions for Clinical Trial Registration Forms are listed in the following table:
State
Managers
User Groups
Default
Planning
DELETE
RELATE
NONE
Active
DELETE
RELATE
NONE
Completed
DELETE
RELATE
NONE
Suspended
DELETE
RELATE
NONE
Locked
DELETE
RELATE
NONE
147
Document Control
Country and Site Registration Form Permissions
The permissions for Clinical Trial Country and Site Registration Forms are listed in the following table:
State
Managers
User Groups
Default
Active
DELETE
RELATE
NONE
Inactive
DELETE
RELATE
NONE
148
Chapter 11
Workflows
EMC Documentum Electronic Trial Master File provides generic workflows to process TMF
documents. Workflows contain tasks that provide business logic to the lifecycle phases and pass
content from one state to another.
This section contains the following topics:
• For Collaborative Editing, page 149
• Submit Document for Review, page 150
For Collaborative Editing
Use this workflow to send a document for collaborative editing before sending it to the review
workflow.
The system automatically performs the tasks with the
the tasks with the
icon. Users with specific roles perform
icon. Users perform the tasks described in the following table:
User Task
Description
Edit document
Reviewers review and edit the document.
Incorporate changes
Authors incorporate the changes from each
Reviewer.
149
Workflows
Related topics:
• Editing a Document in a Workflow, page 93
• Incorporating Document Changes, page 94
Submit Document for Review
Use this workflow to send a TMF document for review.
Users perform the tasks described in the following table:
User Task
Description
For Review
Authors or Reviewers review the document.
Draft
Authors review feedback from the reviewers
and merge the comments from the reviewers.
Ready to be Made Final
Authors release the document to the Final state.
Related topics:
• Reviewing Documents in a Review Task, page 94
• Reviewing Document Feedback from Reviewers, page 95
• Approving Documents, page 96
150
Chapter 12
Troubleshooting
This section contains the following topics:
• Verifying User Roles, page 151
• Connection Issues, page 151
Verifying User Roles
Roles determine the functions that users can execute. If the expected functionality is not available,
verify the user is a member of the role required to execute the functionality. Review the following
topics to understand the available groups and associated roles:
• User Roles, page 25
• Documentum eTMF User Groups, page 128
Connection Issues
EMC Documentum Electronic Trial Master File is a web-based application. If the repository does not
appear or other connection issues occur, verify that the required services are running.
To start the required services:
1.
Log in to the Windows system using the login credentials.
2.
Open the Services console.
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Troubleshooting
3.
Start the following services in the listed order:
a.
Documentum Docbroker Service Docbroker
b. Documentum Docbase Service LifeSciences
c.
Documentum Java Method Server
d. Apache Tomcat
e.
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EMC Documentum Thumbnail Server
Index
A
activating a file plan template, 45
activating a trial, 51
activating the file plan for a clinical trial, 50
adjusting the trial schedule, 50
administer clinical trials, 33
approving documents, 96
associating a file plan template with a
country registration form, 47
associating a file plan template with a
product registration form, 46
associating a file plan template with a site
registration form, 48
associating a file plan template with a trial
registration form, 47
audit a trial, 103
audit trail, 90
control categories, 127
control category
viewing, 98
controlled documents, 71
lifecycle states, 134
creating
clinical trial country registration
form, 36
clinical trial registration form, 35
clinical trial site registration form, 37
content template, 75
file plan, 42
file plan template, 43
product registration form, 34
TMF bulk import-export package, 80
creating a document, 72
creating registration forms for the trial, 46
B
D
building the file plan for the trial, 48
bulk export, 79
bulk import, 79
starting, 85
bulk import-export spreadsheet
populating, 83
dashboards
missing documents by zone, 117
product - trials by status, 115
product - trials table, 114
site - full inventory table, 125
trial - full inventory table, 120
trial - missing documents by status, 119
trial - missing documents by zone, 118
trial - progress history, 122
trial - received documents by
status, 121
trial - schedule status by stage, 123
trial - site status, 124
viewing, 112
defining information in registration
forms, 33
delegating a task, 99
users, 101
workflow supervisor, 100
document
checking in, 75
C
categorizing inbox tasks, 91
checking in, 75
clinical trial
audit, 103
locking, 53
clinical trial country registration form, 36
clinical trial registration form, 35
clinical trial site registration form, 37
clinical trials
set up and administer, 33
viewing dashboards, 111
content template, 75
153
Index
collaborative editing, 93
reviewing, 94
reviewing feedback from reviewers, 95
self-approve, 90
document changes
incorporating, 94
document control, 127
document history, 104
document list
export, 104
document package ZIP file
importing, 85
document status
viewing, 98
document_id, 73
documents
creating, 72
finding, 69, 103
hard delete, 97
remove permanently, 97
withdraw, 96
Documentum eTMF
overview, 9
drag and drop
import file, 67
validate, 49
file plan template
activating, 45
activation, 45
creating, 43
file plan template updates
understanding, 18
file plan templates
understanding trial activation, 16
file plan validation, 48
file plans
understanding, 13
finding
documents, 69, 103, 107
placeholders, 65
finding a registration form, 66
For collaborative editing, 149
E
I
editing a document in a workfllow, 93
eDRG, 129
eTMF structure
updating, 53
existing documents
registration form changes, 54
export
document list, 104
multiple documents, 79
external trial participant access
verifying, 42
external trial participants, 41
registering, 41
registrations, 39
user groups, 131
user roles, 130
import
multiple documents, 79
import and index trial documents, 63
import and indexing process, 63
import documents, 67
import file
drag and drop, 67
placeholder, 67
registration form, 67
importing
document package ZIP file, 85
inbox tasks
categorizing, 91
indexing a document
document list, 68
finalize indexing list, 68
inspector notes
adding, 104
viewing and deleting, 104
internal and external users
security considerations, 40
F
file names, 73
file plan
creating, 42
154
G
giving access permissions
external trial participants, 41
H
hard delete documents, 97
Index
L
R
launch collaborative editing, 89
launch review workflow, 89
lifecycle model
trial registration form, 21
lifecycle states
controlled documents, 134
registration forms, 137
locking a clinical trial, 53
reassigning, 101
reassigning roles, 99, 101
refreshing
bulk import-export spreadsheet, 81
eTMF structure, 53
registration form
finding, 66
import file, 67
registration form changes
existing documents, 54
registration forms
defining document information, 33
understanding, 15
registrations
external trial participants, 39
reinstate a document, 96
reinstate a placeholder, 74
reports
eDRG, 107
missing documents by zone, 117
product - trials by status, 115
product - trials table, 114
site - full inventory table, 125
trial - full inventory table, 120
trial - missing documents by status, 119
trial - missing documents by zone, 118
trial - progress history, 122
trial - received documents by
status, 121
trial - schedule status by stage, 123
trial - site status, 124
restricting access to registration forms, 38
review and approve trial documents, 87
roles, 25, 101
verifying, 151
M
menu functions
TMF documents, 144
TMF placeholders, 143
trial registration forms, 142
multiple documents
import, 79
O
omit a placeholder, 74
overview
Documentum eTMF, 9
P
performers
update, 99
permissions, 145
country and site registration forms, 148
product registration form, 147
trial master file document, 146
trial registration form, 147
placeholder
import file, 67
omit, 74
reinstate, 74
types, 65
placeholder properties
view, 66
placeholders
file plan, 50
finding, 65
product-level, 52
populating
bulk import-export spreadsheet, 83
product registration form, 34
progress tracking
understanding, 18
S
search
documents, 107
security considerations
internal and external users, 40
self-approve a document, 90
services
required, 151
set up clinical trials, 33
share across sites
TMF document, 75
starting
155
Index
bulk import, 85
stop a workflow, 99 to 100
submit for review, 150
superseded, 97
suspending a document, 96
T
task performers
update, 99
TMF bulk import-export package
creating, 80
TMF bulk import-export packaget
zip and export, 81
TMF bulk import-export spreadsheet
refreshing, 81
TMF document
share across sites, 75
TMF placeholders, 50
product-level, 52
TMF reports, 111
TMF structure
understanding, 10
trial
activating, 51
audit, 103
locking, 53
trial master file reports
viewing, 111
trial progress, 53
trial registration form
lifecycle model, 21
trial schedule
adjusting, 50
trial schedule adjustments
understanding, 20
trial statistics, 53
troubleshooting, 151
U
understanding
file plan template updates, 18
file plans, 13
progress tracking, 18
registration forms, 15
TMF structure, 10
trial activation with file plan
templates, 16
trial schedule adjustments, 20
156
update task performers, 99
updating eTMF structure, 53
user groups, 128
Clinical, 130
cross-functional, 129
external trial participants, 131
Reporting, 129
user roles, 25
external trial participants, 130
users
delegating a task, 101
V
validate
file plan, 49
validation
file plan, 48
verifying
external trial participant access, 42
view document properties, 104
view documents side-by-side, 104
view placeholder properties, 66
viewing clinical trial progress, 53
viewing control category, 98
viewing dashboards, 112
viewing document status, 98
viewing the audit trail, 90
viewing trial master file reports, 111
viewing workflow progress, 98
W
withdraw documents, 96
workflow
stopping, 99 to 100
workflow process, 87
workflow progress
viewing, 98
workflow supervisor
delegating a task, 100
workflow tasks
approving documents, 96
editing documents, 93
reinstate a document, 96
reviewing documents in a Review
task, 94
reviewing feedback from reviewers, 95
superseded documents, 97
suspending a document, 96
Index
update performers, 99
workflows, 149
For collaborative editing, 149
launch collaborative editing, 89
launch review, 89
performing tasks, 90
submit for review, 150
Z
zip and export
TMF bulk import-export package, 81
157