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Regulatory Coordinator2 of 6
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Module 1: Lesson 1
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.
That narrative must be accurate, complete, and current. And when you are the RC assembling that narrative for eight studies in the same quarter, the question is not whether you can write a good continuing review package -- it is whether you have built the systems that make good packages a structural inevitability rather than an individual heroic effort.
This is the difference between a coordinator assembling one package from the data they have personally maintained over the past year and an RC assembling eight packages from data streams maintained by multiple coordinators across multiple studies. The individual coordinator's challenge is completeness. The RC's challenge is systematization -- ensuring that the data collection, aggregation, and assembly processes produce consistent quality at scale without requiring the RC to personally verify every data point in every study.
What you will learn
By the end of this lesson, you will be able to:
Regulatory Coordinator
Full course · Regulatory Submissions & Stakeholder Management