If, during the course of your review*, you would like to request that the PI make changes to the study or provide additional information, you can do so via the Request Clarifications activity.

• In Non-Committee Review, requesting clarifications sends the submission back to the study team so they can edit it.
• In Committee Review, requesting clarifications allows the study team to provide a written response but not edit the SmartForm. This is explained in detail below.

*If you would like instruction to request changes as an Ancillary Reviewer, please visit the Requesting Changes as an Ancillary Reviewer page.

To request clarifications on a study in Non-Committee Review:

1. From My Inbox, click the name of the submission to open it.

2. Click Request Clarification... on the left.


3. In the Request Clarification form, provide detailed questions or requests for changes.
Note: You can also attach documents that further explain and/or show suggestions for resolving the problems (e.g. a track changes Word document).

4. Click OK to send the request to the study team and to open the SmartForm for edits. You will receive an e-mail notification when the study team submits their response to the clarification request.

Important! The following items on the SmartForm cannot be changed after a study is submitted(even when clarifications are requested).

• The department chosen on the first page of the SmartForm.  If the incorrect department is indicated here, either (a) withdraw the submission, change the department and resubmit it; OR (b) copy the submission and discard the one with the incorrect department.  Proceed with review of the copied, corrected and resubmitted study.
• The selected attachment category for items included on the last page of the SmartForm. Incorrectly categorized items must be deleted and re-added with the correct category selected.
• For Modifications: the type of modification (study team members only or other parts of the study) cannot be changed once selected.  If the incorrect option is selected, the submission must be discarded and recreated with the correct type chosen.

To request clarifications on a study in Committee Review:

1. From My Inbox, click the name of the study to open it.

2. Click Request Clarification... on the left.


3. In the Request Clarification form, provide detailed questions or requests for changes.
Note: You can also attach documents that further explain and/or show suggestions for resolving the problems (e.g. a track changes Word document).

4. Click OK to send the request to the study team. You will not receive an e-mail notification when the study team submits their response to the clarification request.

Important! Requests for clarifications are handled differently during committee review than during other types of review in that study team members are not solely in control of the submission:

• Study team members cannot edit the study when the clarifications requested are from committee review, but they can submit comments back to the committee.
• Committee members can continue to request clarifications after a request has been made.
• The committee cannot record a decision for the submission when it is in the Clarification Requested state. So, before the meeting, either:
  • The IRB coordinator can remove the submission from the agenda before the meeting and reassign it to a later meeting 
    OR
  • At the time of the meeting, the committee chair or administrator can use the Convene Meeting activity to return all submissions still in the Clarification Requested state to the Committee Review state so the reviews can be recorded.