SaaS eIRB (New eIRB) Frequent Asked Questions


What is the Web address for eIRB and how do I login??

Please see the "eIRB " button on our homepage.

eIRB

Since we are currently in two systems, there are two addresses, and you may need to take an additional step to be able to access the new system.  You can login from that page.

How do I request a password reset?

The eIRB system uses your Emory University ID and Password for logon. If you do not know your Emory University NetID and password please contact the ServiceDesk at 404-727-7777.

How do I receive eIRB notifications if I do not use my Emory email account?

Emory personnel who do not use email to transmit or receive patient or other confidential information can request that automatic email forwarding be activated by completing a request via the Remedy Help Desk system or by calling (404) 727-7777.

Before submitting the request, please review Policy 5.13 Automatic Forwarding of Email from the EmoryExchange Environment.

Please note: Once the forwarding request is submitted, your Emory Exchange account will be deleted and the data will not be recoverable. Your existing Exchange email messages will not be transferred to any other email account and an only new email sent to your Emory email address will be forwarded to the forwarding address specified in the request.

Instructions:

  1. Login to https://emory.service-now.com/
  2. Select Request a Service
  3. Select Automated Exchange Forwarding: Configuration Request
  4. Complete Form

How do I add a person to a study if they do not appear in the list of names?

If the person is affiliated with Emory: 

Every eIRB account-holder will show up in the “name chooser” interface in the eIRB smartform. If you are attempting to add a person who does not show up, he or she may need an account in the new eIRB system. Please go here for more information. 

If the person is not directly affiliated with Emory: 

Those people should normally be added as "External" study team members via uploading a list of names (see Page Level Help for Local Study Team Members). Only add them here if they will be covered by Emory's IRB review - not if they are under their own IRB's review.

For instructions on sponsored accounts, please see the External Users Tab of the eIRB access page.

How do I submit a new study?

Please see the Submit a study in eIRB guidance or the New Study video on this page.

How do I submit a Modification (amendment)?

Please see how to Modification guidance or Creating a Modification video on this page.

How do I submit a continuing review?

Please see how to Continuing Review guidance or the Creating a Continuing Review video on this page.

How do I submit a reportable event?

Please see how to Reportable New Information (RNI) guidance or the Reportable New Information Submission video on this page.

How do I request close-out/termination?

In the new eIRB, this is done via a Continuing Review submission (using the "Createe Modification/CR" button). Please see the Study Closeout guidance.

How do I print a complete application?

In the study workspace at top left, click “Printer Version” to open the document. Then click Print. Click Close when finished.

Why does "Registered User" and/or "Study Staff" appear under "My Roles" and not "PI" or "Coordinator"?

In eIRB, researcher users usually only need the Registered User and Study Team roles.  In reality, of course, different individuals have special roles, such as PI, Co-Investigator, and Coordinator. The user submitting the study in eIRB will assign these roles in eIRB accordingly, and although these users can operate within their assigned functions (e.g., PI can click “submit”), their specific role will not appear under “My Roles.” The names of the PI, Co-Investigators, and Coordinators will show up in the study application after they are entered there.

Who can create and edit study applications?

  • Any eIRB user can create a New Study.
  • Only the PI can submit the study for the first time.
    • The PI can then "Assign PI Proxy" to allow other individual(s) to perform the PI functions (must be done on a study-by-study basis).
  • Only the PI or PI Proxy for that study can submit responses to clarification requests
  • Only the PI or PI Proxy for that study can create and submit follow-on submissions (like Modifications and Continuing Reviews).
  • Any user can create an RNI (Reportable New Information) submission from their main "Inbox" area, and associate the RNI with active studies on which they are listed as study team members.
  • Only PI or PI Proxy for that study can create an RNI submission from within a study.
  • For studies under External IRB review: Only the PI can submit a new study. and PI Proxy can "Update Study Details" or "Create Site Modification." 
    • IRB staff can also do many activities, on External IRB-reviewed studies

Who can "submit" applications in eIRB?

Only the person named as PI in the application can do the initial submission of a New Study in eIRB, after which the IRB can begin its review. The PI or the PI Proxy can submit responses to requested clarifications, and can create and submit follow-on submissions for that specific study. 

Who can submit changes to the application requested by the IRB?

The PI and those designated as PI Proxy for the specific study can do this in the new eIRB.

How does eIRB notify me when I need to do something?

eIRB will send an email to your regular email account if you need to do something. You can click the link in the email to go to the eIRB login page and then to the relevant study. Only the PI, and the PI Proxy(ies) and Primary Contact (if any) will receive automated notifications. The IRB staff can choose to send the notifications associated with logged comments to the whole study team as well. 

How do I ask a department approver to review and approve a study?

After the PI, PI Proxy, or the IRB staff triggers Department review (via "Manage Ancillary Reviews"), eIRB will notify the department approver(s) via their regular email accounts. The department approver can click the link in the email to go to the relevant study. If the IRB does not receive department approval by the time we are ready to approve the study, we will reach out to you with names of who to contact with reminders. 

The Department Approvers will also see your study in their "My Inbox" in eIRB. 

How do I find out the status of my submission?

eIRB shows the “state” of submission in the upper left part of the submission workspace (e.g. "Pre-Review," "Approved," etc). Each state reflects where the submission is in the review process. Please also view the study progress flowchart at the top of the submission workspace, to help you determine where your submission is in the process.

How do department approvers and faculty advisors approve a study?

Please see this link for the Ancillary Reviewer instructional video. 

In summary, the reviewer will follow the link to the study that appears in their email notification. They can view the study smartform via the "Print Version" button at the top left, then click "Exit" at the bottom of the smartform.

Once satisfied, they use the "Manage Ancillary Reviews" button on the left side of the study screen, then click "Update" next to their review to "accept" the study.  If they wish to leave a comment for the study team, they may.