This article covers the following:
- How investigators/submitters can make changes to an in-progress request
- How Reliance POCs/Backups can make changes to an in-progress request
- Making changes after pre-check is complete
All reliance requests first go to the Overall PI's home institution Reliance POC for a "Pre-Check"; this step in the workflow is an opportunity for the POC to identify any areas that require correction, as well as to assess whether the study is eligible for a reliance arrangement.
How investigators/submitters can make changes to an in-progress request
If the request has been submitted but it has not yet passed the Pre-Check step, the submitter of the request can reopen it and make any necessary changes (e.g., correcting a typo in the study title or an email address, or making a change to the requested reviewing IRB) by following these steps:
1) On the Request Details page click the "Reliance Request" link in the left hand column.
2) At the bottom of the subsequent page there will be a button to reopen your request.
How Reliance POCs/Backups can make changes to an in-progress request
If the request has been submitted but it has not yet passed the Pre-Check step, the Reliance POC or the Reliance POC Backup of the Overall PI's Home Institution can send the request back to the submitter for revisions (e.g., changing the requested reviewing IRB or uploading additional documents)
by following these steps:
1) At the bottom right of the Reliance Pre-Check Form, click "Request needs revision."
2) On the subsequent page, you will be prompted to enter a reason for reopening the request, to help the submitter understand what they need to change. The submitter of the request will receive an email notification that the request has been reopened and will be provided with the reasons.
Making changes after pre-check is complete
If the status of the request is “Pre-Check Complete” or “Reviewing IRB Identified” either the submitter or a Reliance POC/Backup may ask for the request to be reopened for revision. Re-opening the request will allow the submitter to make any necessary changes, including adding or removing a site, adjusting site details, changing investigators, uploading new documents, etc. However, reopening a request at this stage will undo any progress that has been made on the request thus far.
To initiate the reopen process, send an email to email@example.com by clicking the link on the Request Details page as shown below. Select the Details link in the Overall Status box to bring up the dialog box with the email link. In your email, be sure to include the reason why you would like the request to be reopened; please be clear and detailed in your explanation.
You can also start this process by clicking the “Revise Request” link at the bottom of the Reliance Request form as shown below.
In order for the SMART IRB help desk to complete the reopen process, we will need an email confirmation from the POC of the Overall PI’s Home Institution (if the request is in a state of “Pre-Check Complete”) or from the POC of the Reviewing IRB (if the request is in a state of “Reviewing IRB Identified”). While we are waiting for that confirmation, we will put an alert notice on the request to ensure no further action is taken.
Once the appropriate POC has confirmed that the request should be reopened and revised, we will send the request back to the submitter, and all parties will be notified. The submitter will then be able to log in to revise and resubmit the request as requested.
Once resubmitted, the request will reenter the workflow, going first to the Overall PI’s Home Institution for review and pre-check.