Sites Initial Submission Observational Minimal Risk Registries: FAQs
A CV is not required for an observational registry site submission. Depending on the answers to the questions on the Observational Registry SIQ, supplemental materials (e.g., for an additional facility or audit information) may still be required.
No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.
You can contact the Site Support Team or your sponsor and they will be able to tell you if the protocol has been approved as an “Observational Registry” study.
You CANNOT submit using the standard SIQ if the study has been qualified as observational registry. Utilization of the standard SIQ will cause your site to be held from review until the complete Observational Registry SIQ is received.
I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?
Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Quorum’s Site Support Team at (877) 472-9883 or firstname.lastname@example.org if you’d like more information about this process.