How to handle new information while a study is in pre-review
Study teams may receive new information about a protocol from the NCI, cooperative group, or drug manufacturer while the study is under IRB review. Depending on when during the review process the information is received and the type of information, it may be incorporated into the current submission, or may need to be submitted for separate review.
What new information may be incorporated into a submission already under IRB review?
- Action letters or other safety-related information
- Updated CAEPR lists
- Updated investigator brochures/package inserts
If a major amendment requiring PRMC approval is received while a study is in pre-review, consult with the assigned IRB staff reviewer to determine next steps.
When is it possible to add new information to an IRB submission already under review?
The submission (initial review, change of protocol, reportable event) must be in the Issues Pending state in ARROW. The study team may ask the assigned IRB staff to move a submission from IRB Pre-review to Issues Pending in order to add new information, or wait until IRB staff sends modifications to the study team.
When is it not possible to add new information to a submission?
- After a submission has been scheduled for an IRB meeting
- If the pending submission is undergoing expedited review and the new information requires review by the full IRB
- If the pending submission is a reportable event and the new information is unrelated to that event
In these cases, the new information must be submitted as a change of protocol after the pending submission has been approved, or the pending submission must be withdrawn.
What if the new information can’t be added to a submission under review?
- Wait until the pending submission is approved, and create a new submission
- For time-sensitive information that must be reviewed as soon as possible, consult with the staff reviewer assigned to the pending submission. It may be necessary to withdraw the pending submission.
How does the study team add new information to a submission under review?
- Revise the application smartform and all study relevant study documents to reflect the new information, and check for consistency among documents.
- Use the Upload Revisions button to upload tracked changes versions of any revised study documents.
- For documents that include revisions due to new information and revisions due to pre-review modification requests, identify the new information by highlighting it in the revised documents.
- Detail the changes made due to new information in the Comments dialog box that appears in the Submit activity form.