I have a change of protocol and a continuing review coming up. Which should I submit first?
Frequently Asked Question
You may have a Continuing Review, a Change of Protocol, and multiple Reportable Events pending at the same time. Therefore, in this case, you should submit your Continuing Review 60 days prior to expiration [Continuing Review Submission Guidance ] and you should submit your Change now, or as soon as you have it ready to submit [How to Complete Changes of Protocol ]. The Staff Reviewers assigned to the Change and to the Continuing Review will work with the Point of Contact to coordinate these reviews, based on the expiration date of the study and the urgency of the change.
And please remember that if the Change is related to the study risks, it may be appropriate to submit a Reportable Event [Adverse Event and Other Incident Reporting ], which may be submitted at any time from the main study workspace [Where do I go to create a new change, personnel change, continuing review, or reportable event in ARROW? ].For more information, see the below document(s).