What do I do with my Site Status Report if I think I am going to close before my expiration?
Quorum requires that all sites submit a valid Site Status Report 45 calendar days prior to expiration. Failure to do so will result in overdue notifications. It is left to your discretion if you wish to hold your Site Status Report at your site until your scheduled closeout visit to avoid going through Periodic Site Review.
If you choose to do so, please bear in mind the following:
- Closing visits are often cancelled or rescheduled. It is a good idea to prepare for Periodic Site Review in case this happens by completing your report and notifying Quorum of the situation.
- If we do not receive the report by the due date, we must adhere to our notification procedures that include a fax and expiration warning letter that is copied to your sponsor. Even if you contact us to let us know that you are planning on closing, you will still receive our overdue notifications as part of our due diligence to assure that no sites expire.
- If the report is not received within 14 calendar days of the expiration date, your site will be scheduled for IRB review. Upon review, the IRB may consider your failure to comply with the requirement to submit a Site Status Report as an instance of noncompliance. Please note that findings of noncompliance are reported to the sponsor and the FDA.