Mid-study IRB transitions: managing regulatory documentation and notification requirements
Applies systematic transition management for mid-study IRB changes, designing stakeholder notification workflows and evaluating risk points including gap periods, consent continuity, and continuing review date resets.
The regulatory event that has no margin for improvisation
A mid-study IRB transition is, in my assessment, the single most complex regulatory event that an RC manages at the site level. It is more complex than an initial submission, because all the components of a new submission must be prepared while an existing regulatory relationship is being terminated. It is more complex than a continuing review, because the continuity of oversight must be maintained across two different IRBs rather than renewed within one. And it is more complex than a study closure, because the study continues -- with participants enrolled, interventions ongoing, and data being collected -- throughout the transition.