When is the latest point at which a site should complete deregistration?
Although deregistration can take place earlier, the latest that a site should deregister is after the primary analysis of the study is complete.
How do we know when the primary analysis is done?
Sites may inquire with the protocol team.
Can a site deregister if the protocol is still open at the IRB/EC?
Yes, after consulting with the IRB/EC, the site may deregister if all participants are off study or protocol is closed to follow up. Protocol specific safety documents will not be sent to the site. However, the monthly safety distribution report can be found on the RSC website.
Will we need to file for continuing/annual review if the study is closed at the IRB/EC?
If a CRS closes a protocol with the IRB/EC, then it is not required to submit continuing review to the IRB/EC. If the CRS did not close the protocol with the IRB/EC then the CRS is required to submit continuing/annual review. If the CRS has not closed with the IRB/EC but has deregistered with DAIDS, the CRS does not have to submit the documentation of continuing/annual review to the DAIDS PRO but must keep it in CRS’ regulatory files at the site.