Building the continuing review package: study status, enrollment data, adverse events, and protocol deviations
Teaches the RC to systematize continuing review package assembly through standardized data collection processes, staggered preparation workflows, and modular templates adaptable across IRBs.
The package that tells a study's year
A continuing review package is, at its core, a narrative. It tells the IRB what happened on the study over the past approval period: how many participants were enrolled, what adverse events occurred, what deviations were documented, whether the consent form changed, and whether the risk-benefit assessment that justified the study's initial approval still holds. The IRB reads this narrative and decides whether the study should continue.