How to submit a change with a 90-day review deadline
Below are tips for submitting changes of protocol for cooperative group studies that require IRB review and approval within 90 days.
How should the study team inform the IRB office of a 90-day deadline?
In the comment box of the Submit activity form, note that there is a 90-day deadline for IRB review of the amendment. Specify the deadline date (i.e. the date when the 90 days expires).
What if the study team forgets to include a comment in ARROW about review timeline requests?
If the study team forgets to include a review timeline request in ARROW when submitting the application, the study team must contact the assigned IRB staff reviewer via email to communicate the request. Determinations about review priority are made at the discretion of the IRB Office.
What if there are other submissions pending for the protocol?
ARROW allows only one submission at a time. If another submission is pending when the study team receives a 90-day change, consult the IRB staff reviewer assigned to the pending action. It may be necessary to withdraw the pending submission so that the 90-day change can be submitted.
What else can the study team do to help ensure timely IRB review?
- Submit the change of protocol as early as possible
- Prompt submission is especially important if the change is a major amendment requiring PRMC review and approval prior to IRB review.
- Make the change application as complete as possible
- This is true for all submissions, but especially in the case of time-sensitive changes, be sure to:
- provide a detailed summary of the amendment
- provide an analysis of the impact of changes on risk/benefit ratio
- revise the initial review application and supporting documents to incorporate the changes
- check for consistency among documents
- Respond promptly to reviewer notes during pre-review