eIRB
Amendments Reference Guide
This guide contains detailed, step-by-step instructions for creating, submitting, reviewing and approving Amendments in the eIRB.
For a general introduction to the eIRB, including how to navigate the different workspaces, please see the General Reference Guide.
TAble of contents
How to Log In to eIRB 2
How to View Your Task Lists 2
For Study Staff 3
How to Create and Submit a Study Amendment 3
How to Electronically Sign an Amendment 15
How to Respond to Reviewer Requests 19
For Reviewers 25
How to Complete Your Review 25
How to Request Changes of the Study Team 37
Getting Help 40
Technical Support 40
eIRB Home 40
eIRB Email 40
DHTS Help Desk 40
Research Support 40
IRB Office 40
DOCR Office 40
How to Log In to eIRB
1. In your internet browser, go to the eIRB Home page: http://eIRB.mc.duke.edu .
2. Type your NetID, tab to the password field and type your NetID password, and click the Login button or press the Enter key.
Your personal workspace displays.
How to View Your Task Lists
Your eIRB Task List is designed to show you work that is awaiting your action. Each eIRB role assigned to you has its own Task List.
1. Click the white My Home link at the right of the top blue banner.
Your roles are listed under the My Roles heading in the column at the left. The Task List for the selected role displays in the main section of the window. The selected role is shown in the colored banner at the top, and in bold text under the My Roles heading. To return to your Task List from anywhere in the eIRB, click the My Home link again.
2. To view the Task List for a different role, click the role under the My Roles heading in the column at the left.
For Study Staff
Amendments can be created for Approved studies. One amendment can be open at a time.
· To change the edit rights or email notification option for study personnel, use the Modify Existing Study Personnel activity. These changes do not require an amendment.
· To add or remove study personnel, create and submit a Personnel Change Request.
How to Create and Submit a Study Amendment
1. To find Approved studies, click the white Studies link in the top blue banner.
Studies on which you are a member of the study team display.
2. Click the link under the Name column to open the study workspace.
The study workspace displays.
3. Click New Amendment under the Create heading in the column at the left.
The Amendment Request Form displays.
4. Complete the Amendment Request Form, explaining the proposed changes. Click Continue to save and proceed.
The Confirmation of Changes page displays.
5. Click Finish.
Finish begins the process of creating a copy of the approved study, called the Modified Study.
You will make your proposed changes to the Modified Study. When the proposed changes are approved by the IRB, the Modified Study becomes the Approved study.
You are returned to the amendment workspace, with the following message displayed:
The amendment is being created in the background. You can log out of the eIRB system or do other work while the amendment is being created. Return to this page, or refresh the page, to update the status.
You can leave this page and continue working while the copy is being created. When you refresh or return to the amendment workspace and the message no longer displays, the copy is complete. The copy process can take up to 30 minutes. To return to the amendment workspace, you can find the amendment in your task list (click the My Home link in the top right of the blue banner) in the Items in Presubmission folder.
6. Click => Modified Study Workspace in the column at the left, from the amendment workspace.
The Modified Study workspace displays.
7. Click Edit Modified Study in the column at the left.
The first page of the Modified Study displays for editing.
8. Go the appropriate study pages and make the proposed changes and/or attach revised documents directly on the pages. Save the pages and exit the application.
For more detailed information about these steps, see the General Reference Guide.
When you exit the application pages, you are returned to the Modified Study workspace. Changes to the study pages appear as entries in Change Log.
9. When all of the proposed changes have been entered, click <=Amendment Workspace in the column at the left to return to the Amendment workspace.
The Amendment workspace displays.
10. Click the Submit Amendment button in the column at the left.
The Submit Amendment window displays.
11. Click the checkbox and Click OK.
The Amendment moves to the Awaiting PI Signature state and an email notification is sent to the PI.
How to Electronically Sign an Amendment
1. To view your Task list, click the My Home link in the top blue banner. Study Personnel must be selected under My Roles in the column at the left.
2. Click the link under the Name column to open the Amendment awaiting PI signature.
The Amendment workspace displays.
3. Click Electronically Sign Amendment in the column at the left.
The Electronically Sign Amendment page displays.
4. Click the checkbox to confirm and click OK.
The activity is displayed in the study History, and the study moves forward to the next reviewer.
How to Respond to Reviewer Requests
When changes are requested, responding is a two-step process. First, make the changes to the Amendment Request Form and/or the Modified Study. Second, submit the change to notify the reviewer.
1. To view your Task list, click the My Home link in the top blue banner. Study Personnel must be selected under My Roles in the column at the left.
2. Click the link in the Name column to open the amendment workspace.
The request displays in the History folder.
3. To change the Amendment Request Form, click View/Edit Amendment.
To change the Modified Study, click =>Modified Study Workspace, then Edit Modified Study. Go to the appropriate pages and make the changes or attach revised study documents directly on the pages. Save and Exit the Modified Study pages to return to the Modified Study workspace.
Please note: If you are planning to make any changes other than those requested by the reviewer, please first contact the reviewer. Some changes are handled by the eIRB workflow, but some must be managed manually by the reviewer or IRB staff.
Changes to the Modified Study appear as entries in the Change Log.
4. Click <=Amendment Workspace to return to the amendment workspace.
5. Click Submit Changes in the column at the left..
6. Enter a summary of the changes and click OK.
Your comments display in the History tab. An email notification is sent to the Reviewers and the study is removed from your task list.
For Reviewers
How to Complete Your Review
1. To view your Task list, click the My Home link in the top blue banner.
2. Click the link to the amendment under the “Name” column to open the amendment workspace.
The Amendment workspace displays.
3. Click View Amendment to view the Amendment Request Form.
The Amendment Request form displays.
4. Click the Exit link at the top of the page to return to the amendment workspace.
The Amendment workspace displays.
5. Click => Modified Study Workspace to view the Modified Study.
The Modified Study is a copy of the Approved study that contains the changes proposed in the amendment.
6. Click Printer Friendly Version in the column at the left to view a scrollable version of the Modified Study.
The first page of the Modified Study displays..
7. Click Close at the top right of the page to return to the Modified Study workspace.
The Change Log folder contains the changes made to the study pages.
8. Click the link to the right of the paper and pencil icon to view the changes on the page.
The Approved study page and the Modified study page show side by side. Data differences are highlighted in red. Changes in attached documents only show as different dates.
9. Click Back to Change Log at the top right of the page to return to the Modified Study workspace.
10. Click <=Amendment Workspace to return to the amendment workspace.
11. To complete the review:
· For Pediatrics Risk Assessment
o Click Complete Pediatric Risk Assessment in the column at the left.
o Select the risk radio button, enter a comment as applicable, and click OK.
o Continue with the For Specialty Committee Reviewers instructions below.
· For Specialty Committee Reviewers
o Click Complete Specialty Committee Review
o Enter comments as applicable. Click the radio button indicating your specialty committee and click OK.
o The activity is recorded in the History and the amendment moves forward to the next reviewer.
How to Request Changes of the Study Team
1. Click the Request Changes as Specialty Committee activity in the column at the left.
2. Type a comment and attach checklists or revised study documents as applicable, and click OK.
The request displays in the History folder.
An email notification is sent to the study team. When the changes are made and submitted, an email notification is sent to you and any other required Specialty Committee reviewers, and the amendment is added to your Task list.
Please note: Please review all changes made by the study team, to ensure complete review. Some changes are handled by the eIRB workflow, but some must be managed manually by the reviewer or IRB staff.
Getting Help
Technical Support
eIRB Home
See http://eIRB.mc.duke.edu for help logging in to the eIRB, User Guides, and Frequently Asked Questions (FAQ).
eIRB Email
Email to contact IRB IT staff for help using the eIRB.
DHTS Help Desk
Call the DHTS Help Desk at 684-2243 for help with network connectivity, NetID and NetID password.
Research Support
IRB Office
See http://IRB.mc.duke.edu for guidance and information from the IRB Office.
DOCR Office
See http://docr.som.duke.edu for guidance and information from the Duke Office of Clinical Research.
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