Regulatory Coordinator

Full course · Regulatory Submissions & Stakeholder Management

Managing continuing review across 15+ studies: batching, staggering, and the 60-day rule — Regulatory Submissions & Stakeholder Management

Managing continuing review across 15+ studies: batching, staggering, and the 60-day rule

Teaches portfolio-level continuing review management strategies: calendar analysis for workload distribution, batching decisions for same-IRB studies, and the 60-day rule as a portfolio standard.

23 min

The calendar problem no one teaches you about

You have learned what happens when a continuing review lapses. You have learned how to build the packages efficiently. Now comes the question that separates a coordinator managing studies from a regulatory coordinator managing a portfolio: how do you manage the timing?

Consider a site with 18 active studies. Each study has its own IRB approval date, set not by the site's convenience but by whenever the initial approval was granted -- which in turn was determined by whenever the study happened to start. The result is 18 continuing review deadlines scattered across the calendar with no regard for your workload capacity, your PI's availability, or the rhythms of your other regulatory obligations.

At most sites, these deadlines are not scattered evenly. They cluster. A site that opened five new studies during the same quarter three years ago now faces five continuing reviews converging in that same quarter, every year, in perpetuity. And the clustering compounds: the annual continuing review cycle repeats at the same time each year, so a difficult quarter this year will be a difficult quarter next year, and the year after that, unless someone intervenes to redistribute the workload.

That intervention is the subject of this lesson. It is, in my view, some of the most practically valuable work the RC does -- and it is almost never discussed in training programs, because it requires portfolio-level visibility that training programs designed for per-study coordinators simply do not address.

What you will learn3 objectives

By the end of this lesson, you will be able to:

Design a staggering strategy that distributes continuing review preparation workload across the year rather than allowing it to cluster in peak periods
Apply batching strategies for studies reviewed by the same IRB, consistent with ICH E6(R3) Annex 1, Sections 1.4.3--1.4.4
Evaluate the trade-offs between early submission and just-in-time submission, calibrated by study risk level and IRB processing reliability

Progress saves itself — finish reading and this lesson completes

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The calendar problem no one teaches you about