Cancer Center: Handling New Information During Pre-review

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?

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?

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be submitted as a change of protocol after the pending submission has been approved, or the pending submission must be withdrawn.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?

How does the study team add new information to a submission under review?