Protocol Registration Entity Approvals Frequently Asked Questions

What does the term “REs/Approving Entity” include?

Any group other than the local IRB/EC who is responsible for reviewing and/or approving a clinical research protocol and site-specific ICFs prior to implementation at a site. Refer to the Definition section of the Protocol Registration Manual for additional details.

What type of documentation will be accepted as proof of IRB/EC submission within 45 days?

Examples of appropriate documentation of the date an amended protocol/LoA and any revised site-specific ICFs were submitted to the local IRB/EC include but are not limited to:

  • the submission letter from the site to the IRB/EC
  • a memo from the IoR or designee specifying the date of submission to the IRB/EC

Are IBC approvals required for Amendments and LoAs?

IBC approvals for LoAs and amendments may or may not be required. If an IBC must review and approve all full version protocol amendments and LoAs prior to the implementation at a CRS, documentation of the IBC approval should be submitted to the DAIDS PRO at the time of amendment or LoA registration.

If RE/Approving Entity is not responsible for review and approval of full version protocol amendments, LoAs or continuing/annual reviews, will each submission for the same protocol and site require a separate statement in comments section of DPRS?

No. This is a onetime requirement per protocol/site. If documentation is submitted with the initial registration or with the first full version protocol amendment registration, the site does not need to submit documentation for any subsequent registrations for that protocol. However, if the local regulations change, the IoR for the trial is responsible for ensuring that DAIDS is aware of these changes.

If a local IRB transfers/delegates purview/authority to another IRB (e.g. between a central IRB and the institution's IRB), what documentation should be provided by the site?

Approvals from all IRBs listed on Form FDA 1572/DAIDS IoR form need to be submitted. If one IRB designates responsibilities to another, written documentation form the IRB that states delegation of authority to the other IRB is required.

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