Five Reasons Why You Should Close a Protocol Instead of Letting it Expire
Formally closing the protocol is an investigator responsibility. The process signals the date IRB oversight is no longer required. Allowing a protocol to expire is not an acceptable alternative to submitting a closure request.
When submitting a closure request, E-IRB asks a series of questions to determine whether the study meets regulatory criteria for closure. FDA, pre-2019 Common Rule, and 2019 Common Rule regulations differ in this regard.
The answers to the closure questions also tell you whether a Final Review is needed. Many studies will be able to close without completing a Final Review.
Closing the protocol allows the audit and records retention timelines to begin. UK IRB policy requires investigators to maintain their research records (signed documents and IRB records) for six years after completion of the study.
IRB closure records have been relied upon by investigators as a source of information for funding organizations, regulatory agencies, and reporting in clinicaltrials.gov.
To submit a closure request for your study, select
