Common Protocol Template
Guidance for Use
Last Updated 29 April 2016
Last Updated 29 Jul 2015
About this Guide
This Guide is for use with the Common Protocol Template (CPT) CPT-Technology Enabled EditionVersion 3.0. It is provided to assist with set up and utilization of the technology enabled edition of the
TransCelerate Common Protocol Template and associated Microsoft Word add-ins. The format of the
training contains a mixture of text and graphics and is accompanied by a series of brief video clips. If
additional guidance is needed from the TransCelerate Common Protocol Template Workstream, contact
[email protected].
1. Background/Architecture Outline
To create a single template applicable to all study phases and types, the CPT uses a modular approach to
manage information. The Core Backbone establishes a common heading structure and recommended
content applicable to all protocols, while content specific to participant type or disease area are
separated into libraries. The disease area libraries contain recommended objectives and endpoints as
well as disease-specific content to facilitate adoption of Therapeutic Area Data Standards.
To facilitate the user experience, manage the diverse information components, and enable reuse of
content, the Technology Enabled CPT was created within the MSWord environment. Utilization of a
metadata driven XML framework further facilitates content reuse and establishes the foundation for
traceability and automation.
Key requirements listed below are achieved through native Word functionality (with the creation of
customized add-ins and use of content controls):
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A Microsoft Word template with XML backbone
Instructional text displayed in a separate pane beside the document
Linkage of library and core - automates importing library text in appropriate sections of the
protocol
Reuse of content via variables for key protocol terms, automatically reflects edits in all
occurrences
Ability to export key protocol terms and content, and ability to import into other tools
Linkage of Objectives to Endpoints
Common Protocol Template
Guidance for Use
2. Template Set up & Administration (Sponsor Level)
Installation
Installation should be able to be performed by the end user in most cases. Detailed installation
instructions are provided along with system prerequisites in the CPT Installation Instructions. The
installation of the Technology Enabled CPT is managed via “one click” installation capability found at the
following location: http://www.transceleratebiopharmainc.com/assets/common-protocol-template/.
Included in the package is a Prerequisite Utility that evaluates the user’s system configuration for
compatibility. Note: Version 3.0 is compatible with Word 2007, 2010, 2013 and is not compatible with
any Apple Operating system.
Customization
Customization – Core Backbone and Available Libraries
Many of the benefits of the Common Protocol Template stem from consistent use, which should enable
a better user experience for key stakeholders (e.g., sites, IRBs, regulators). That being said, some degree
of customization will be needed, including any changes necessary to align with company specific
formatting standards and branding. Sponsors may also want to introduce disease area specific content
in areas not yet addressed in the current version. The level of customization should be determined by
any company who chooses to adopt.
Customization – Additional Libraries
The ability to incorporate company-specific libraries is being developed for a future release.
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3. User Orientation
My Templates / CPT Templates Tab
This customized storage location for the CPT Core Backbone is described in the CPT Installation
Instructions and allows for easy location of the Core Backbone when launching a new document in
MSWord. For example, when starting a new protocol from the template, Word 2010 users will navigate
to File/New/My Templates/CPT Templates tab to launch the CPT Core Backbone if it was stored as
instructed. For more details, consult the CPT Installation Instructions.
Navigation Pane
By enabling the navigation pane in the “View” tab of Word, the user will be able to see an interactive
TOC within the CPT that will allow easy navigation throughout the sections of the template.
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Guidance for Use
Data Sources Pane
The Data Sources Pane displays information related to
the various libraries that are linked to the CPT Core
Backbone. It displays appropriate instructional
content as you navigate through the template as well
as relevant library content for inserting into the draft
document. Specifics of each component are in the
box to the right and displayed in the screenshot
below:
Understanding the
Data Sources Pane
a. Filter Library List Box Panel
Displays the libraries that have been
designated for use in the protocol.
b. Instructional Text Box Panel
Displays the instructional text associated with
each first and second level heading of the
template. Clicking within the content control of
the heading will display the relevant
instructional text here. Additionally, libraryspecific instructions will be displayed when
navigating through the library content tree
view.
c. Library Content Tree View Panel
Displays a tree view hierarchy of the available
content from selected libraries for a particular
area/content control within the template. The
entries within this window represent the tree
view structure for the selected libraries as a
reference only, allowing the user to review how
the library content is organized.
When there IS relevant data to the content
control, the window will show an additional
tree view under the bolded heading of
“Available Content”. Any available text will be
bolded within the tree view as the user
expands sections. Double clicking one of these
bolded headings will insert that content into
the document content control area.
If a particular content control (represented in
the template with “enter information here”
prompts) does NOT have any related data in
the selected libraries, only these first two
references will be present.
d. Preview Text Box Panel
Displays the relevant content for review when
the user single clicks on one of the bolded
content headings in the tree view. This enables
the user to review the text before importing.
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CPT Tab
The CPT Tab within Word appears upon installations of the customized CPT add-ins. Users should
navigate to this tab in order to utilize the following customization elements described below and
displayed in the screenshot: (though present in the user’s version of Word when working in any
document, they will only be functional when working within the CPT Core Backbone template)
a. Add Variables – allows the users to insert content controls for common protocol elements that are
regularly used in multiple places throughout a protocol. By inserting the content control and
defining the element text, the user ensures that edits to those elements will be replicated
consistently throughout the document wherever the same variable is in use.
See “CPTV1_AddVariablesButtonTrainingVideo.mp4”
b. Delete – Some content controls cannot be deleted using MS Word delete functionality because they
may have related content controls or elements associated with them. For example, deleting an
objective may render associated endpoint in orphaned state. Due to this reason, you need to delete
content controls associated with variables such as these using the Delete option in the ribbon.
See “CPTV2_DeleteButtonTrainingVideo.mp4”
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Guidance for Use
c. Example Text Tools “Convert” – In the Example Text Tools sub menu of the CPT Tab, the “Convert”
button will convert example text found in the document to plain text. There is a drop down menu
that gives us the below 2 options under convert
i.
Convert Example Text and Move Next – By selecting this option from the drop
down, only one instance of example text will be converted to plain text and the
curser will move to the next set of example text in the document.
ii.
Convert All Example Text in Document– This selection in the drop down will
convert ALL example text in the document.
d. Example Text Tools “Remove” – In the Example Text Tools sub menu of the CPT Tab, the “Remove”
button will remove example text found in the document. There is a drop down menu that gives us
the below 2 options under remove
i.
Remove Example Text and Move Next – By selecting this option from the drop
down, only one instance of example text will be removed and the curser will
move to the next set of example text in the document.
ii.
Remove All Example Text in Document– This selection in the drop down will
remove ALL example text in the document.
e. Example Text Tools “Next” – The “Next” button will help us navigate through the CPT document and
locate each instance one by one of example text.
See “CPTV3_ExampleTextToolsTrainingVideo.mp4”
f.
Useful Links – The useful links contains a dropdown of links users may find helpful while working in
the CPT template. Currently this is configured to show a link to CPT User Resources and a CPT
Feedback form on the TransCelerate site.
See “CPTV4_UsefulLinksButtonTrainingVideo.mp4”
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g. About – The about button contains version information for each of the add-ins, log files, a section to
manage templates for the CPT, and an advanced settings tab which helps control user access to
administrative functions.
 Manage Templates –Through the “Manage Templates” section users have the ability to update
to the latest version of the CPT Template. For example, this is where you might have someone in
your company who maintains template versions and manages the updates as they are released
from TransCelerate. This person may store the template at an internal share point site or a local
file location. A user could then populate the “Manage Templates” section with this information
to update to the latest release from TransCelerate.
a. Upon expanding this section, populating the File URL text box, and clicking the “Check
for Updates” option a user will be able to check for updates for the CPT Template. Once
the template has synchronized a message will appear and a user will close the window
and dialog box and be able to use the most current template.
b. The File URL text box may be populated by a CPT Template saved as a .DOTX or .DOTM
file and by one of the below 2 ways:
i.
A folder created on the user’s PC where updates are pulled down and stored
from the TransCelerate site (Example: C:\Users\angelica.capper\Desktop
ManageCPTTemplates\CPT-TechEnabled-V2.01.dotx)
ii.
A URL in a share room site that contains the updates.
 Advanced Settings - Through the “Advanced Settings” section users will be able to control access
to the CPT Admin tab. The default for this option will be unchecked
See “CPTV5_AboutButtonTrainingVideo.mp4”
h. Instructional Text – clicking on this icon allows the user to “toggle” the Data Sources Pane on and off
if desired.
See “CPTV6_InstructionalTextButtonTrainingVideo.mp4”
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CPT Admin Tab
The CPT Admin Tab within Word is established with the installations of the customized CPT add-ins. To
view the CPT Admin Tab, users will need to click on the “About” button on the CPT Tab, go to advanced
settings, and click the check box for “Show CPT Admin Tab”. Users should navigate to this tab in order to
utilize the following customization elements described below and displayed in the screenshots: (though
present in the user’s version of Word when working in any document, they will only be functional when
working within the CPT Core Backbone template)
i.
Manage Variables – this component will allow the creation/management of additional customized
variables and will be addressed in a future release of the CPT.
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j.
Export Data – allows the user to export the predefined elements in the protocol document into an
XML format which could be consumed by other systems if desired. Detailed instructions can be
found later in this training guide.
k. Import Data -- similar to the export, an external file’s data appropriately tagged with metadata
corresponding to template content controls, could be imported to integrate those tagged elements
into the CPT content controls. Use of this function is at the individual sponsor’s discretion.
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4. Creating a New Protocol
Create a New Protocol Document
1. Click on New > My Templates > CPT Templates > CPT Core Backbone (Word 2010) Consult CPT
Installation Guide for specific path in Word 2013.
2. Save the file
3. If necessary, enable the Navigation Pane found in the View tab.
Configure Library Filters
See “CPTV7_ConfigureLibraryFilesTrainingVideo.mp4”
1. Go to the Data Sources Pane. Click on the Filter funnel.
Select libraries by dragging libraries
from “Available Libraries” to the appropriate panel (e.g., Therapeutic Area panel or Participant
panel).
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The below libraries are the current libraries for Release 3 of the CPT:
Participant Type Libraries
V2.1_CPT Library_Healthy Volunteer Master.docx
V2.1_CPT Library_Patient Master.docx
Therapeutic Area Libraries
V2.1_CPT Library_Asthma Master.docx
V2.1_CPT_Library_Diabetes Master.docx
Note: All other libraries listed are for historical purposes and should not be used when authoring
a new CPT.
Note: Custom filter functionality will be addressed in a future release.
2. Click OK to create the protocol document using the libraries selected.
3. If a user wishes to not use a Therapeutic Area, they can leave this box empty. A user will have to
select a participant type to utilize the template. If no Therapeutic Area or Participant Type is
selected, a user will see the below message.
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5. Authoring the Protocol
Accessing Instructional Text
See “CPTV8_InstructionalTextPaneTrainingVideo.mp4”
CPT Core Backbone instructional text is maintained in a file separate from the template and linked to
content controls in each of the first and second level template headings where applicable. To access this
instructional information:
1. Click on a Level 1 or Level 2 heading content control.
2. Review the relevant instructional text in the Instructional Text Box Panel. If no instructional text
exists for a particular heading the Instructional Text Box Panel will be empty.
Additionally, there is instructional text embedded in various sections of the Therapeutic Area and
Participant Type libraries. To access this instructional information:
1. Click on relevant Available Content Tree View headings (for example, within the Library Content
Tree View Panel when the Diabetes TA Library is enabled, clicking on the Primary
Endpoints/Hemoglobin H1C heading will surface related instructional information in the
Instructional Text Box Panel)
2. Within the Tree View, as you begin to drill down through the levels, if more granular
instructional details exist at each level, they will be displayed at the top of the Instructional
Panel with each previous related level displayed and separated by ~~~~~~ so that all relevant
instructions will be displayed at once.
Completing the Title Page
In order to utilize some of the variables for common protocol terms, they should first be entered on the
Title Page.
1. Complete Title page fields: some of these fields are key protocol terms found in the Add
Variables add-in, and are or can be used in other places within the document. For example,
Protocol Title is repeated in the Synopsis. Once values are entered into the variables on the title
page, the values will be replicated in any other occurrences.
Note: If you begin to enter content into the CPT before configuring the Library filters as described
above, you will be prompted with a reminder message that at least a participant library needs to be
selected. See screenshot below.
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Formatting Conventions
As you begin to work within the CPT, you will notice several styling conventions. These formatting
conventions are described in the table below:
Type of
Text
Description
Format
Style
Common
Headings
Heading levels 1 and 2 which
should not be altered or
deleted (Indicate “not
applicable” if that is the case.)
Black, Times New Roman, 14pt, Bold
Heading 1,
Heading 2
Suggested
Headings
Heading levels 3 and beyond
which are suggested but
optional, intended to be
customized if appropriate for
the study
Black, Times New Roman, 14pt, Bold
Headings other
than Heading 1
and Heading 2
Common
Text
Common language intended to
remain consistent across
protocols
Contained between <Start of Common
Wording> and <End of Common
Wording>
Normal
Black text, Times New Roman
Suggested
Text
Suggested language to be used
in optional sections, which can
be deleted if not needed
Black text, Times New Roman
Normal
Variable
Text
Wording to be replaced
dependent on individual study
needs
[blue bracketed]
The blue is the darker blue from Word
“Standard Colors”. R:G:B of 0:112:192.)
Normal
Example
Text
Example text to be removed by
the author prior to publishing
via an add-in
Arial, 10pt, Italic, green
The blue is the darker blue from
Word “Standard Colors”. R:G:B of
0:176:80.
CPT_Example
Instructional
Text
Instructional and guidance text
intended to aid in authoring of
the protocol in this template
Will appear in the Instructions Pane
CPT_Instructional
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Red, hidden text in any version not
utilizing the technology enhancements
(i.e., if provided without use of the
instruction pane). Should be removed by
the author prior to publishing
Common Protocol Template
Guidance for Use
Drafting Protocol Content
Once the title page is completed, drafting of other protocol content can begin anywhere in the
document. All areas where text is to be entered have been defined with content controls to “tag”
sections of content for export into XML format (one of the powerful benefits of the Technology Enabled
CPT). These content controls will turn gray when hovering the cursor over them. They may either
contain a guiding statement such as, “Enter text here” or may have example text already populated in
them. See screenshot below:
Once in the content control the user can type new text, append to existing content or delete sections as
necessary. Once a section is complete, the user should also ensure that the appropriate style format is
established (e.g. if deciding to utilize example text it should be converted to the appropriate “Normal”
style desired in the final document.)
In addition to basic text entry in the CPT, there are specialized methods for utilizing the various content
components of the CPT (e.g. Key Protocol Variables, Library content). These are described in more detail
below.
Note: Users will be unable to add comments or view tracked changes in content controls that are
‘locked for editing’ from Microsoft word.
Using Variables for Key Protocol Terms (Content Controls)
See “CPTV9_VariableValueTrainingVideo.mp4”
As described earlier, the CPT defines a number of Key Protocol Terms that are typically used multiple
times throughout a protocol. By creating these as Intelligent Content Management Variables within the
CPT Add-in Tab, the user can define them one time and use them throughout the document ensuring
that subsequent editing is accomplished consistently throughout the protocol.
To insert a variable:
1. Place cursor in the intended location for the variable content.
2. Click on CPT tab in the Word tool bar.
3. Click the down arrow next to “Add Variable” to expose the variable pick-list.
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4.
5.
Click on the desired variable name to insert the Variable Content Control at the cursor location.
Enter text into the content control if the variable has not previously been defined in the
document.
Several of the key protocol term variables allow the user to create multiple instances. An example is
“Dose Formulation” which will allow the user to create ‘Formulation 1’, ‘Formulation 2’, Etc.
As described earlier, in addition to facilitating re-use of content and ensuring consistency throughout
the document, content controls are the foundation for building traceability of content throughout the
protocol (e.g. relationships with objectives & endpoints). To accomplish this, users will utilize the
content control variables in conjunction with library content to build these relationships. These
template behaviors warrant more detailed discussion below.
Accessing & Utilizing Library Content
Throughout the CPT various content controls have been linked to specific content within the
Participant Type and Therapeutic Area libraries. As the user navigates into specific content controls
where these relationships/mappings exist, the relevant library content is displayed within the Library
Content Tree View Panel as described earlier in this document.
Note: When utilizing/inserting library text into various sections of the template, it is best to insert any
library text first and THEN edit or add additional text as required. In certain cases, the insertion of
library content could “wipe out” existing text if inserted after already drafting a section. This is possible
when the inserted content is an image or table vs lines of text.
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Updating Objective and Endpoints Table (Section 4)
See “CPTV10_ObjectivesEndpointsOverviewTrainingVideo.mp4”
When creating the Objectives and Endpoints table within the CPT, the author may draft new text entries
or utilize standard content from the Therapeutic Area Library content. The entire table serves as a
content control and each row in the first column will serve as its own objective. Every bullet point in the
second column will serve as an endpoint that matches to the objective on the same row and
relationships are established and maintained within the Key Protocol Variables utility. Screen shot
below:
Go to Section 4 Objectives and Endpoints of the template and click inside the first row and first
column of the Objectives and Endpoints Table. You will notice the entire table is a content
control. In the example video, the Asthma Library is enabled so the Library Content Tree View
Panel displays the available content hierarchy.
2. To the left of the screen, expand the Primary Objectives heading to display available content
choices.
1.
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3.
Single click on one of the bold content descriptors. This will display the full content within the
Preview Text Box Panel below the Tree View Panel.
4.
Double click the bold content descriptor to insert the text for the first primary objective.
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5.
Next, go to the first row and second column to add the first primary endpoint for the first
primary objective. A user can do this by expanding the Primary Endpoints heading to display the
available content choices, highlight and double click to insert the content into the location. To
enter an additional endpoint simply click enter to add another bullet and insert the content
from the available choices. (A user may also type out the desired endpoints)
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6.
Next, add a row below to add another primary objective. A user may type out the desired
objective or add from the available content in the library.
Repeat these same steps through the Secondary and Exploratory Objective table cells as
needed.
8. As a user enters the objectives and endpoints in the table, the Add Variable button on the CPT
tab contains all of our updates. If required a user would be able to add an entered objective or
endpoint elsewhere in the CPT Template. On the CPT Tab click the “Add Variables” button and
choose Primary Objective 2 and click. This will add a new content control for the second Primary
7.
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Objective elsewhere in the document. *Note this Content Control will be read- only, as edits to
the objective and endpoints are controlled through the Objectives and Endpoints Table in
Section 4
9.
As you establish the individual objectives and endpoints, the Variable Add-in generates the
corresponding Endpoint Variables mapped to each objective. For example when you expand the
Primary Endpoint variable at this point in the process, it already contains the objectives entered
and the endpoints mapped showing accurate traceability.
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10. If you would like to delete an individual objective or endpoint, simply delete the rows as
appropriate.
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Updating Objective and Endpoints Table in Synopsis Section
See “CPTV11_ObjectivesEndpointsSynopsisTrainingVideo.mp4”
The objectives and Endpoints table that appears in the synopsis sections is generated from the table
that is created in Section 4 Objectives and Endpoints of the CPT Template. When a user first opens the
template the Synopsis section will appear as below:
After a user populates the Objectives and Endpoints Table in Section 4 they will follow the below steps
to update the synopsis table:
1.
After populating the Objectives and Endpoints table, the Library Content Tree View, displays a
section entitled “Table Data” with the newly entered Objectives and endpoints.
2.
You will notice that the last level in the tree view is the endpoint mapped to an objective and
may contain a checkmark. The checkmark will indicate whether an objective and endpoint
combination will be entered into the synopsis table. By default, all primary endpoints will
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contain this checkmark and a user will have to double click the empty space next to each
secondary objective they want to include in the synopsis table. Once the selections have been
made a user will click the blue refresh button to update the synopsis table (the words
“Processing” will appear). Upon completion of the update, the template will refresh and the
cursor will relocate to the Synopsis section which will contain the selected objectives and
endpoints represented in a summary table.
3.
Special Note: Every time a user edits /enters/exits the Objectives and Endpoints table in section
4, the default selection will occur. This means that a user will have to manually select the
secondary objectives every time an edit is made if and update is needed for the synopsis table.
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Exclusion Criteria List
See “CPTV12_AppendingExclusionContentTrainingVideo.mp4”
Building the table of Exclusion Criteria is similar to how we build the Objectives and endpoints table in
that the content controls are already embedded within the listing. Each content control is aligned with a
category of exclusion criteria (Medical Conditions, Diagnostic Assessments, etc.) and multiple criteria
can be inserted into the control. Each criteria that is inserted will append to the last text and numbering
will automatically adjust. To create the Exclusion Criteria list:
1. Click in the content control for Exclusion Criteria/Medical Conditions. The available library
content will appear in the Library Tree View Panel.
2. Navigate to the desired bold content descriptor. Single click to review and double click to insert
into section.
Repeat this process to insert all relevant criteria for the first section. (Notice the automated
numbering)
4. Additional custom criteria can be drafted for Medical Conditions at this time.
5. Move to the content control for the next Exclusion Criteria section and repeat the process.
6. Repeat for all subsequent sections.
3.
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Exporting & Publishing the Document
See “CPTV13_ExporToXMLTrainingVideo.mp4”
Variables and the content of certain sections tagged with content controls can be exported to an XML
file. The XML file can be used to import the information into other software packages (Excel, etc.)
Specific instructions for this capability are below:
1. Once you have completed authoring your protocol, navigate to the CPT Admin Tab and click the
“Export Data” Button. (If you do not see the CPT Admin Tab go to the CPT Tab, Click on the
“About” button, Go to Advanced Settings and check the box called “Show CPT Admin Tab”)
2. Select the namespace (Protocol or Variables) you want to export and then type or navigate to a
location you want to save your export to. Then click export when completed. You will see the
words “Export Completed” when you export is finished.
a. Protocol – selecting this option will allow users to export the data entered while
authoring the protocol. For example, if a user enters objectives and endpoints, exclusion
criteria, or Protocol Number these items will be populated in the export.
b. Variables – selecting this option will allow users to export the variable definitions from
the CPT template for the purpose of creating a different template. This is more of an
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administrative function for use if a user ever wanted to author a different type of
document and utilize the same variables created in the CPT.
3. A dialogue box will appear as your export is exporting. You can open the XML in Internet
Explorer to take a look at the data that has been exported.
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a. Exporting Protocol
b. Exporting Variables
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