eIRB
General Reference Guide
eIRB Home: http://eIRB.mc.duke.edu
eIRB Technical Support: [email protected]
Institutional Review Board
Duke University Medical Center
IRB Office: http://irb.mc.duke.edu
IRB Office Phone: (919) 668-5111
Introduction .......................................................................................................................... 1
System Requirements ....................................................................................................................1
System Configuration .....................................................................................................................1
How to Set the Size of Letters ..............................................................................................................................1
How to Configure your Browser to Use Microsoft Word to Open Documents ...................................................1
How to get an eIRB Account ...........................................................................................................2
How to Log in.................................................................................................................................2
Navigating eIRB .................................................................................................................... 3
The eIRB Banner ............................................................................................................................3
Your Name ...........................................................................................................................................................3
My Home ..............................................................................................................................................................3
Login / Logoff .......................................................................................................................................................3
eIRB Home............................................................................................................................................................3
Administration .....................................................................................................................................................3
Studies ..................................................................................................................................................................3
Exploring Your Personal Workspace ...............................................................................................4
My Home ..............................................................................................................................................................4
My Roles ...............................................................................................................................................................4
Viewing All of Your Studies ............................................................................................................4
How to Use the Display Tabs ................................................................................................................................4
Finding a Study ..............................................................................................................................5
How to View Studies Awaiting Your Action .........................................................................................................5
How to Search for Studies using Filtering Criteria ...............................................................................................5
How to Sort Studies..............................................................................................................................................5
Exploring the Study Workspace ......................................................................................................5
Study Header........................................................................................................................................................5
Application Pages .................................................................................................................................................6
Review Status .......................................................................................................................................................7
Actions Available ..................................................................................................................................................7
Tabs ......................................................................................................................................................................7
Exploring the Amendment Workspaces ..........................................................................................8
Amendment Workspace ......................................................................................................................................8
Modified Study Workspace ..................................................................................................................................9
Exploring the Safety Event Workspace .......................................................................................... 10
Safety Event Header ...........................................................................................................................................11
Safety Event Pages .............................................................................................................................................11
Exploring the Continuing Review Workspace ................................................................................ 11
Continuing Review Header .................................................................................................................................11
Continuing Review Pages ...................................................................................................................................12
Using the eIRB: How To and Tips .......................................................................................... 12
Tips for Completing Study Pages ................................................................................................... 12
Required Fields ...................................................................................................................................................12
Tips for Selecting People .............................................................................................................. 12
How to Add People to Study Pages ....................................................................................................................12
How to Remove People from Studies ................................................................................................................13
How to Find People to a Add to a Study ............................................................................................................13
Tips for Finding Funding Source, Sponsor, Drug or Device Source .................................................. 13
Tips for Attaching Documents ...................................................................................................... 14
How to Find Attached Documents .....................................................................................................................14
How to View an Attached Document .................................................................................................................14
How to Attach a Document ................................................................................................................................14
How to Replace an Attached Document with an Updated Version ...................................................................14
How to Detach All Versions of a Document .......................................................................................................14
Tips for Naming Attached Documents ...............................................................................................................14
How to Save Email Correspondence ..................................................................................................................15
How to Manage Paper Documents ....................................................................................................................15
Attaching Other Media ......................................................................................................................................16
Tips for Consent Forms................................................................................................................. 16
How to Copy the eIRB Consent Form Template .................................................................................................16
Tips for Responding to Reviewer Requests.................................................................................... 16
Tips for Using Microsoft Word ...................................................................................................... 17
Tips for Getting Help with Microsoft Word........................................................................................................17
Tips for Tracking Changes to a Document..........................................................................................................17
Tips for Reviewing Tracked Changes ..................................................................................................................18
Tips for Accepting and Rejecting Tracked Changes ............................................................................................18
Tips for Comparing Documents..........................................................................................................................18
Troubleshooting .................................................................................................................. 19
Getting Started ............................................................................................................................ 19
Getting Help ................................................................................................................................ 20
Login Help ..........................................................................................................................................................20
FAQ .....................................................................................................................................................................20
User Gudies ........................................................................................................................................................20
eIRB Support ......................................................................................................................................................20
System Maintenance.................................................................................................................... 20
Emergency Preparedness ............................................................................................................. 20
Introduction
The eIRB is a software application that enables researchers to submit human subject
research protocols to the DUHS Institutional Review Board online, using a web browser.
The eIRB Home page address is: https://eirb.mc.duke.edu. Protocols submitted in the
eIRB are routed, reviewed, and finalized electronically.
This General Reference Guide gives you basic information that will familiarize you with
using the eIRB. In the User Guides section of the eIRB Home page, there are rolespecific user guides with detailed, step by step instructions for eIRB activities.
System Requirements
To use the eIRB system, you’ll need the following:

An eIRB account

Compatible web browsing software. Currently the following web browsers
are fully supported:
o Internet Explorer version 7 or higher
o Mozilla Firefox version 3 or higher
o Apple Safari version 4 or higher

Sun Microsystems Java software

Software capable of reading Microsoft Word 2007 (.docx) documents

Software capable of reading .pdf documents

An active internet connection
System Configuration
How to Set the Size of Letters
The recommended minimum screen resolution for eIRB is 1024 X 768. To
change your resolution, go to the Display Control Panel and click the Settings tab.
Move the screen resolution slider to 1024 X 768, and click the Apply button.
How to Configure your Browser to Use Microsoft Word to Open Documents
In eIRB, many documents are attached, much like e-mail attachments. You can
configure your browser to open documents in specific software applications, such
as Microsoft Word, based on the file extension. Otherwise, your browser might
open attachments in the browser’s extensions which do not have full functionality.
1
To configure Internet Explorer to use Word to open Word documents:
1. Open My Computer.
2. On the Tools menu (or the View menu), click Folder Options (or click
Options).
3. Click the File Types tab.
4. In the Registered file types list, scroll to the DOC extension (Microsoft
Word Document) row, and select.
5. Click Advanced (or click Edit).
6. In the Edit File Type dialog box, click to clear the Browse in same
window check box (or click to clear the Open Web documents in
place check box).
7. Click OK.
8. Click Close.
How to get an eIRB Account
On June 1, 2011, we implemented a new process for creating new accounts in the eIRB.
First, please complete the Duke Human Subjects Protection (HSP) training requirements.
For information about the training requirements, see
http://medschool.duke.edu/modules/som_research/index.php?id=10.
One to two business days later, an eIRB account will be automatically created for you.
How to Log in
1. In your internet browser, browse to the eIRB Home Page at:
https://eirb.mc.duke.edu
2. At the eIRB Home page, type your NetID and password in the
appropriate fields in the column on the right side of the page.
3. Click the Login button.
If your login is successful, you will see your name on the right side of
the top blue banner.
If your login is not successful, click the Log In Help link on the eIRB
Home page, or see the logging in sections of the eIRB Troubleshooting
Guide in the User Guides section of the eIRB Home page.
2
Navigating eIRB
The eIRB Banner
The eIRB banner, the Duke blue area across the top of the page, contains several
navigational links.
Your Name
The name link in the top right of the blue banner displays your contact
information. This information is loaded from Duke institutional databases, and
must be updated at the source. Directory information can be updated at
Online@Duke, at www.duke.edu/online. You might need to contact your
departmental payroll or human resources representative about updating your
contact information.
My Home
The My Home link, located in the top right of the blue banner, displays your eIRB
task-list. The task-list displays eIRB items that are awaiting your action. If you
have more than one role in the eIRB, you will have a separate task-list for each
role. You can switch between roles using the links in the left column of your
workspace.
Login / Logoff
The Login / Logoff links in the top blue banner log you in or off of the eIRB.
eIRB Home
The eIRB Home link is on the left side of the top blue banner. The eIRB Home
page displays news and information about the eIRB, and contains links to helpful
information such as the User Guides and Downloadable eIRB Forms.
Administration
The Administration link in the top blue banner gives Organization administrators
access to all of the studies in their Organization, as well as related Amendments,
Safety Events and Continuing Reviews. Studies are divided into folder tabs based
on review status.
Studies
The Studies link in the top blue banner gives study team members access to all of
their studies and related Amendments, Safety Events and Continuing Reviews.
Studies are divided into folder tabs based on review status.
3
Exploring Your Personal Workspace
My Home
When you log in to the eIRB or click the My Home link at the right of the top
blue banner, you see your personal workspace. Personal workspaces are designed
to help you manage your eIRB work.

“Workspace for [your name]” heads the page

The My Roles column at the left shows the roles assigned to you

A Tasklist folder tab shows the eIRB items that are awaiting your action
To return to your personal workspace at any time, click the My Home link in the
top blue banner.
My Roles
If you have more than one role assigned to you in the eIRB, the study and task-list
information you see depends on the selected role. The selected role shows in the
color bar at the top of the left column, and as the role in Bold under the My Roles
heading.
To view the workspace for a different role, click that role name under the My
Roles heading.
To view all eIRB items awaiting your action, you will need to select each
different role you have, and view each task-list.
Viewing All of Your Studies
Click the white Studies link in the top blue banner to find studies to which you
have access as a member of the study staff ( PI, Co-PI, Study Coordinator,
Faculty Sponsor, Other Key Personnel).
Click the white Administration link in the top blue banner to find studies to which
you have access as an administrator (e.g. Department Chair, Research Support
Office).
These studies might not require action, but you always have access to view them
through the Studies or Administration link.
To view all Amendments, Continuing Reviews or Safety Events, click those links
from the column at the left Studies page.
How to Use the Display Tabs

The “All” tab displays all studies to which you have access, in any state of
review.

The “In Progress” tab displays your studies under review.

The “Approved” tab displays active studies.
4

The “Inactive” tab displays your studies that have been closed or
withdrawn.
Finding a Study
How to View Studies Awaiting Your Action
Click the My Home link in the top right of the blue banner. The eIRB task list
displays all studies that are awaiting action by your or by someone with your role
in the eIRB.
If you have more than one role under the My Roles heading in the column at the
left, you have a Task list for each role. Click the name of each role to view studies
awaiting action by you or someone with your role in the eIRB.
How to Search for Studies using Filtering Criteria
Within each study folder (All, In Progress, Approved, Inactive), you can search
for one or more studies by using criteria as filters.

The default way to search for a study is by Protocol ID number. Type the
number (e.g. Pro00000001) in the text box in the light blue header and
click the Go button.

To change the criteria for selecting studies, click the Filter By drop down
arrow. select an item to filter by (e.g. PI), enter the criteria in the text box,
and click the Go button.

If you only know part of the criteria, you can use the % wildcard, (e.g.
Filter by Name, type %asthma in the text box and click Go).
How to Sort Studies
Studies are sorted by Protocol ID, in ascending order. To change the sort order,
click the column heading on which you want to sort. Click the column heading
link again to sort in the opposite order.
Exploring the Study Workspace
The study workspace is the home page for a study. You see the study workspace
when you click on the study name from your home page or the Studies link.
The study workspace gives you information about where the study is in the
review process, as well as access to the study application pages and all
information associated with the study.
Study Header
The study header is the rows of information in the top middle of the workspace
that displays identifying information about the study. The amount of information
displayed in the header changes as the study goes through the review process.
5
The study header always displays:

Study - the short title of the study

Protocol ID - the protocol ID number Proxxxxxxxx

Full Study Title

Study Organization - the organization responsible for the study

SBR – Site Based Research organization

Prinicpal Investigator

Study Coordinator

Funding Source(s)

Protocol Source(s)

Review Type – the IRB review type: Expedited, Full Committee, or
Exempt

Primary Reviewer

Review Date

Current Expiration Date

Letter of Approval – [View] link to approval of new study
Application Pages
Printer Friendly Version
The printer friendly version displays the study application pages in a
scrollable format that is more suitable for printing.

To scroll through the study pages, click in the scroll bar to the
right of the window

To view an attached study document, click the name link to open
the document. Click the X at the top right of the document to close
it.

To print the view, scroll to the top and click the Print button

To close the view and return to the study workspace, scroll to the
top and click the Close button
View Study
To display the study application pages one at a time, click the View Study
or View / Edit Study button in the column at the left of the study
workspace. Your role on the study and the current state of the study
determine whether or not the study is editable.
6

The protocol number shows at the top right of the study
application pages.

To move through the study pages, click the Continue and Back
buttons.

To view an attached study document, click the name link to open
the document. Click the X at the top right of the document to close
it.

To jump to a different study page, click the arrow next to the
Jump To: drop down box.

To save the study page, click the Save link in middle of the top
light blue banner.

To exit the study pages and return to the study workspace, click
the Exit link in the middle of the top light blue banner.
Review Status
There are three areas of the study workspace that show the review progress and
current status:
Current State
The Current State in the white rectangle at the top of the column to the left
column shows the review status of the study.
History Tab
The History tab in the bottom half of the study workspace shows the
review activities. Each activity shows the name of the person who
executed the activity, and when.
o The review activities display in order, with the most recent
activities at the top.
o To see continuation of comments, click the activity link. Click the
Back button in your browser to return to the History tab.
Actions Available
The links under the Actions Available header in the left column of the
study workspace show the review activities that are available to you.
Actions include Submit Study, Submit Changes, etc. Your role on the
study and the review status determine the actions available.
Tabs
Additional tabs are available, depending on the review status of the study.
7
Study Documents
The Study Documents folder tab is a shortcut view to all documents
attached to the study, such as research summary, consent forms, and
protocol documents.
Information
The Information folder tab is a shortcut view to information from the
study pages.
Required Approvals
The Required Approvals folder tab shows the names and/or organizations
of the study reviewers that are required and received.
Amendments
For approved studies, the Amendments folder tab shows amendments to
the study. To view an amendment and its review information, click the
name of the amendment to go to its workspace.
Safety Events
For approved studies, the Safety Events folder tab shows Adverse Events,
Protocol Deviations, and Correspondence and Other Problems/Events that
Require Prompt Reporting to the IRB. To view a safety event and its
review information, click the name of the safety event to go to its
workspace.
Continuing Reviews
For approved studies, the Continuing Review folder tab shows Continuing
Reviews, including the Annual Progress Report and Final Progress Report,
if applicable. To view a continuing review and its review information,
click the name of the continuing review to go to its workspace.
Modifications
The Modifications folder tab shows all required modifications, if
applicable.
Change Log
The Change Log folder tab shows all changes made to the study by Study
Staff after PI signature.
Exploring the Amendment Workspaces
Amendment Workspace
The amendment workspace is the home page for an amendment. You see the
amendment workspace when you click on an amendment name from your home
page, the Amendments folder on a study workspace, or the Amendments link
from the Studies link in the top blue banner.
8
The amendment workspace gives you information about where the amendment is
in the review process, and access to the Modified Study workspace. The Modified
Study is a copy of the Original Approved study. The Modified Study must contain
all of the changes proposed in the Amendment Request Form. When the
amendment is approved by the IRB, the Modified Study becomes the Approved
study.
The amendment workspace is similar to the study workspace, but has some
unique features.
Amendment Header
The amendment header always displays:

Amendment: - AMD # - the short title of the approved study plus
(Amd#_Pro00000xxx) – the amendment sequence number and the
Protocol number of the approved study

From the Original Approved study (the Parent Study of the
amendment):
o Protocol ID
o Short Title
o Approval Date

From the Modified Study:
o PI - the person who will be the Principal Investigator when
the amendment is approved
o Study Coordinator – the person who will be the Study
Coordinator when the amendment is approved
Amendment Form
The amendment form is the one-page Amendment Request Form that
describes the proposed changes to the study.
Modified Study Workspace
The Modified Study has its own workspace. The modified study workspace
displays when you click on the To Modified Study Workspace button from the
amendment workspace. Changes proposed in the amendment must be made to the
application pages of the Modified Study.
The modified study workspace gives you information about the changes that have
been made to the Modified Study, and access to the Modified Study application
pages.
Modified Study Header
The modified study header always displays:
9

Modified Study and Change Log for: The number and name of the
amendment, AMD# plus the short title of the study

Modified Study #: MS# plus the Protocol number of the original
study

Amendment created date

Amendment review status
Modified Study Application Pages
When you View or Edit Modified Study, the pages containing the changes
in the proposed amendment display. On page 01. Study title and Research
Personnel, the Short Title is the short title of the Original Approved
version, plus (modified study).
Modified Study Folders
Change Log
The Change Log allows you to see the differences between the
Original Approved study and the Modified Study as proposed in
the amendment.

All changes display, in date order, with the most recent
activities first.

To view the changes, click the Notepad icon (

To return to the Modified Study workspace, click the Back
to Change Log button at the top right.
).
Notes: If there are multiple entries in the History for each
study page, you only need to view the Change Log of the most
recent entry for that page.
The Change Log cannot highlight all of the information on the
Detail pages. For Drugs, Devices, and Subject Recruitment
Detail pages, you must look at and compare the information on
the pages and the modified dates for attached documents.
Study Documents
The study documents attached to the Modified Study.
Exploring the Safety Event Workspace
The safety event workspace is the home page for the safety event. You see the
safety event workspace when you click on a safety event name from your home
page, the Safety Events folder on a study workspace, or the Safety Events link
from the Studies link in the top blue banner.
Safety Events include:

Adverse Events
10

Protocol Deviations

Correspondence

Other Problems or Events Requiring Prompt Reporting to the IRB
Safety Event Header
The safety event header always displays:

Safety Event Type – Adverse Event, Protocol Deviation/Violation,
Correspondence or Other Problem/Event Requiring Prompt Reporting to
the IRB

Event Name

Event Description

Protocol Name – the short title of the study

Protocol ID – the Protocol ID number Proxxxxxxxx

Safety Event ID – the Safety Event ID, eg. SAE001_Proxxxxxxxx

Date Event Occurred

Principal Investigator

Study Coordinator

Review Date

Action Notice – [View] link to IRB action notice
Safety Event Pages
You can View or Edit the Safety Event pages one page at a time, or use the
Printer Friendly Version to display the pages in a scrollable format that is suitable
for viewing and printing.
Exploring the Continuing Review Workspace
The continuing review workspace is the home page for the continuing review.
You see the continuing review workspace when you click on a continuing review
name from your home page, the Continuing Reviews folder on a study workspace,
or the Continuing Reviews link from the Studies link in the top blue banner.
Continuing reviews include:

Continuing Review Progress Reports (renewals)

Final Progress Reports (closure)
Continuing Review Header
The continuing review header always displays:
11

Continuing Review CR#: Short Title of the study

Protocol ID

Full Study Title – the full title of the study

Principal Investigator:

Study Coordinator:

Expiration Date - expiration date of the Original Approved study
Continuing Review Pages
You can View or Edit the Continuing Review pages one page at a time, or use the
Printer Friendly Version to display the pages in a scrollable format that is suitable
for viewing and printing.
Using the eIRB: How To and Tips
Tips for Completing Study Pages
Required Fields
Required fields are preceded by a red asterisk. You can Save, Exit, and Jump To
other study pages without completing the required fields. However, the Continue
button checks for errors on the page, so you must complete the required fields to
continue to the next study page. When you submit a study, all the pages are
checked for required fields.
Tips for Selecting People
How to Add People to Study Pages
For some roles, such as PI, you add one person to the role. For others, such as CoPI, you can add more than one person. These are the steps for adding people to a
study.
Single Person Roles
(PI, Study Coordinator, Faculty Sponsor, Key Personnel)
1. Click the Select… button.
2. On the Select Person page, find the person.
3. Click the radio button in front of the person’s name.
4. Click OK.
Multiple Person Roles
(Co-PI)
12
1. Click the Add button.
2. On the Select One or More Persons page, find the person.
3. Click the check box in front of the person’s name.
4. Click OK. If you want to add another Co-PI, click OK and Add
Another.
How to Remove People from Studies
Single Person Roles
(PI, Study Coordinator, Faculty Sponsor, Key Personnel)
Click the Reset… button.
Multiple Person Roles
(Co-PI)
1. Click the check box in front of the person’s name.
2. Click the Remove button.
How to Find People to a Add to a Study

On the Select a Person window, type any part of the person’s Last Name
in the text box and click the Go button. The list is sorted by Last Name
only. To sort by First Name too, click the First column heading.

To find people within common last names, or to search using different
click the Advanced link to the right of the text box. Type any part of the
person’s Last Name and First Name and click the Go button.

To search by criteria other than Last Name, click the drop down box next
to Filter by, select the item to filter by, enter the criteria in the text box,
and click the Go button.
If you are adding people to an Approved study, they will not appear on the list
unless their Human Subjects Protection (HSP) certification is current.
If you are adding people to a new study and cannot find them, they might not
have been loaded properly, or might not have been assigned the required role.
Please send email to eIRB Support at: [email protected].
Tips for Finding Funding Source, Sponsor, Drug or Device Source
On the Select a ? window, type any part of the name in the text box and click the
Go button. The list is sorted by ? To sort by another column, click the column
heading.
If you cannot find a match, the entity will need to be added to the eIRB database.
Send email to eIRB Support at: [email protected].
13
Tips for Attaching Documents
Study documents and reviewed documents are attached in a way that is similar to
adding attachment to e-mail.
Many reviewers use Track Changes in Microsoft Word to indicate required
changes to study documents. Please attach the Research Summary, Consent
Forms, and Waivers as Microsoft Word documents that are editable.
How to Find Attached Documents
Documents attached by Study Staff can be found in the Study Documents folder
tab of the study workspace, or on the individual Study Pages.
Documents attached by Reviewers can be found in the History folder tab of the
study workspace.
How to View an Attached Document
Click the title link of the attached document
How to Attach a Document
1. Click the Add button.
2. Click the Browse button.
3. Navigate to the file that you want to attach, select it, and click Open.
4. Click OK on the Submit a Document window.
How to Replace an Attached Document with an Updated Version
1. Click the Update Revision link in front of the title of the attached
document.
2. Click the Browse button.
3. Navigate to the file that you want to attach, select it, and click Open.
4. Click OK on the Submit a Document window.
How to Detach All Versions of a Document
1. Click the check box in front of the title of the attached document.
2. Click the Delete button.
Tips for Naming Attached Documents
In the eIRB, you can retain multiple versions of the same document. The
attachment Title is not the same as the File Name. The Title is a pointer to the
attached files, some of which have different file names, e.g. “ICF Minor Ver.
1.5.doc”, “ICF Minor Ver. 1.6 tracked.doc”, etc.
14
When you first attach a document, if you leave the Title field blank, the eIRB uses
the file name, e.g. “ICF Minor Ver. 1.5.doc” as the Title. However, you might
decide to type in a more generic Title instead, such as “Minor Consent” or “Adult
Consent”. Then, when you attach different files, revised versions of the same
document, you don’t have to revise the Title.
When you Edit an attachment to attach a revised version of a document, if you
leave the Title field blank, the existing Title is retained. It does not change to
match the file name of the newly attached document.
How to Save Email Correspondence
You can save Lotus Notes email correspondence as a text file so it can be attached
in the eIRB:
1. Open the email correspondence
2. Click File, Export
3. Type the file name and click OK.
Be sure to name the file with a “.TXT” extension at the end. This will
allow the eIRB to recognize the file as generic text.
Attach the saved text file as you would any other document. For details, see the
How to Attach a Document section of this document.
Note: If you have Adobe Acrobat installed (Adobe Reader is not sufficient), you
can save correspondence with the formatting preserved:
1. Open the email correspondence
2. Click File, Print
3. Select Adobe PDF as the printer and click OK.
4. Revise the file name if needed and click Save.
How to Manage Paper Documents
All documents must be attached in eIRB in electronic format. This includes
investigator brochures, patient diaries, and protocols. Please request electronic
documents from sponsors. If you cannot obtain electronic copies, they must be
scanned.
We recommend saving scanned documents in PDF format rather than TIF,
especially large documents.
You can use a third party for large jobs, such as the Duke Copy Center on
Kangaroo Drive. Contact Della Atkins at the Copy Center for more information.
New customers to the Duke Copy Center will need to set up a new account with
the following information: department name, fund code, the name, Duke box
number, phone, and fax number for the person responsible for the fund code.
Another option is Kinko’s on Ninth Street. They will scan to disk as a PDF file
15
for 30 cents/page for 1 -100 pages, with a $10 min. There is a 24-hour turnaround.
Color scanning costs more.
Attaching Other Media
Any electronic media can be attached in the eIRB, including image files and
Windows media files such as AVI and MPG files. If you have media that you
cannot submit in electronic format, go to the study page on which you would
normally attach the media, and attach an explanation of the circumstance, along
with a label identifying the material. Deliver the media to the IRB office, clearly
labeled with the media label, the study name, the PI name, and the eIRB Protocol
ID number.
Tips for Consent Forms
In the eIRB consent forms must have the eIRB-specific footer. The consent form
footer is used by the IRB office to mark the approved consent form. The footer
replaces the rubber IRB stamp that is used for consent forms reviewed on paper.
How to Copy the eIRB Consent Form Template
1. In your Internet browser, go to the eIRB web site:
http://eIRB.mc.duke.edu.
2. Click the Download Forms link in the left column.
3. Click the name of the appropriate consent form template.
4. Save the template on your computer
5. Type your consent form, or copy and paste it from another source, and
Save.
Tips for Responding to Reviewer Requests
Reviewers can use tracked changes in Microsoft Word to request specific changes
to study documents. Study Staff can use track changes to respond. Each person
must make it clear to the other which changes are requested, and/or accepted. This
can be challenging in an electronic world.

Submit Clean Documents
When you submit a study for review, and after each point in the review where
reviewer changes or modifications are necessary, study documents should be
submitted clean, without any unaccepted tracked changes.

Use Track Changes to Show Revisions
When a reviewer requests changes to a document, or the study team requests
revisions, all changes must be tracked.

Use Accept / Reject Tracked Changes to Show Agreement or Disagreement
16
When you agree with tracked changes, accept all changes and attach a clean copy
of the document on the eIRB study page. If you are responding to a request with
changes, or are changing a document in any way different from the reviewer’s
tracked changes, you can reject tracked changes, and/or track your changes and
attach the revised document to the study page. Wait until you have agreement on
all of the changes before attaching a clean copy of the document for final
approval.
Tips for Using Microsoft Word
In the eIRB, it is useful to know how to use Microsoft Word to track and accept
revisions to study documents, and to compare documents to highlight differences.
Tips for Getting Help with Microsoft Word
Context Sensitive Help
When you are in Word, you can click the Question Mark icon or use the
F1 function key on your keyboard to get help with the function you are
using.
Microsoft.com
Microsoft offers extensive help for using Word on their Microsft Office
Online and other web sites available through Microsoft.com.
For example, this is a site for Word 2007 help:
http://office.microsoft.com/en-us/word/FX100649251033.aspx
Duke Resources
Duke Learning & Organizational Development (L&OD) offers classes and
workshops. For schedules, see: www.hr.duke.edu/train
Duke Office of Information Technology is piloting On line training via
Lynda.com, including videos that guide you through software
applications. To get involved, see:
http://www.oit.duke.edu/help/training/online/
Tips for Tracking Changes to a Document
 To save a copy of the file you plan to revise, on your local computer,
right-click your mouse on the name, select Save Target As…, browse
to the place where you would like to save the document and click OK.
 Open the document you saved on your computer in Word, and turn
Track Changes On. In Word 97-2003, Track Changes is on the Tools
menu and on the Reviewing Toolbar. To display the Reviewing
Toolbar, select View, Toolbars, Reviewing.
17
 Open Word documents using Word, instead of the Internet Explorer or
other browser extensions of Word. See the Configuring Your Internet
Browser section above.
 You can change the way your revisions display by changing the Track
Changes Options:
Show changes in Balloons that appear in the margins of the document,
or In Line, in the document.
Show all changes ( e.g. include Formatting changes), or select only
some.
Select where the Indicator that a line has changed displays.
Tips for Reviewing Tracked Changes
 You can change the view of the document by making a selection in the
using the Reviewing Toolbar drop down box:
Original displays how the original document looked before tracked
changes were made.
Original Showing Markup shows the revised document view as a
document marked up by hand with a pen might look. Deletions are
crossed out in the text. Insertions show in the margin.
Final Showing Markup shows how the revised document will look
once the changes are accepted, but with the tracked changes marked
Final shows how the document will look when all changes are
accepted.
 To show all tracked changes in a list, open the Reviewing Pane..
In the Reviewing Pane, double-click on the header of the change to
jump to that place in the document.
Tips for Accepting and Rejecting Tracked Changes
 You can accept and reject changes one at a time, or review all of the
changes, then accept or reject all of them in the document at once.
 Comments are not tracked changes. Comments must be inserted and
deleted. They can not be accepted and rejected.
Tips for Comparing Documents
You can Compare documents in Word to find out where differences exist
between documents.
 You can find the answers to the questions:
18
What are the differences between two documents?
For example, compare two clean documents, an original and a revised
version in which changes have not been tracked.
Did I track all of the revisions to the original document?
For example, compare an original and a revised document with
changes tracked. All differences should show as tracked changes.
Did I accept all of the tracked changes?
For example, compare a tracked document you reviewed with a clean
version. Word compares the tracked changes as if they were accepted,
so there should be no differences in the documents.
 In Word 97-2003, you open the revised document, then compare it to
the original document saved on your local computer. In Word 2007,
you open both documents from your local computer.
 You can change the way differences display by changing the Compare
Options:
Show differences in the Original, Revised, or a third New document.
Show all difference ( e.g. include Formatting differences), or select
only some to reduce the noise in the document.
Compare at the Character or Word level, e.g. show changing the word
“dog” to “frog” as dfrog or dogfrog.
Troubleshooting
Getting Started
If you are unable to view the eIRB Home page:

See if you can access other Duke systems that would normally travel over
the network, such as the IRB Office web site: http://IRB.mc.duke.edu. If
you cannot get to other sites, you are probably having general connectivity
problems. Contact your local computer support person or the DHTS Help
Desk at 684-2243.

If you can go to other sites, make sure you have typed the correct address
for the eIRB Home page in your Internet browser. The address is:
http://eIRB.mc.duke.edu

If you can go to other sites, but cannot view the eIRB Home page, there
might be a technical problem with the eIRB. Email eIRB Support at
[email protected].
19
Getting Help
Login Help
For help logging in to the eIRB, go to the eIRB Home page and click the Login
Help link in the column at the right.
FAQ
For answers to frequently answered questions, go the eIRB Home page and click
the FAQ link in the column at the left.
User Gudies
For step by step instructions, go to the eIRB Home page and click the User
Guides link in the column at the left.
eIRB Support
If your questions are not answered in this document or by following the links
above:
1. Contact your local eIRB support person. For a list, see the Department
Support Contacts document in the User Guides section of the eIRB
Home page.
2. Contact the Board Specialist for your department in the IRB office. For
a list, see the Departments by Board Specialist and Writer section from
the IRB Office link at the top of the IRB Office web site:
http://IRB.mc.duke.edu.
3. Email eIRB Support: [email protected].
If you find the performance of the eIRB unacceptable, send email to eIRB
Support at: [email protected] .
System Maintenance
Announcement of eIRB unavailability for planned maintenance will be made in
advance in the News section of the eIRB Home page. Before the planned
maintenance begins, you should make local copies of any study information that
you anticipate you will need while the system is unavailable.
Emergency Preparedness
Study personnel must maintain local copies of any eIRB study information, such
as approved consent forms, that must be available if the eIRB system is
unavailable.
20