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Module 1: Lesson 1
Timeline architecture: mapping regulatory milestones across concurrent studies
Teaches the RC to build and maintain a portfolio-level regulatory timeline that makes deadline clusters and resource conflicts visible weeks or months in advance
A continuing review is not a date -- it is a cascade
A continuing review deadline is not a date on a calendar. I want to be very precise about this, because the distinction matters enormously at portfolio scale. The date the IRB stamps on the approval letter -- the date by which your continuing review must be approved or your study's authorization lapses -- is the end point of a process that began 60 to 90 days earlier. Someone had to pull enrollment figures. Someone had to compile deviation summaries. Someone had to update the consent document comparison. The principal investigator had to review the package and sign it. The IRB had to receive the submission in time to schedule it for a convened meeting or route it through expedited review. Every one of those intermediate steps has its own time requirement, and every one of those time requirements competes with the same obligations for every other study in the portfolio.
This is the problem that portfolio-level timeline architecture solves. Not "when are things due?" -- any calendar can tell you that. The real question is: "When must work begin, for every milestone, for every study, simultaneously -- and where do those work-start dates collide?"
The previous lesson established the portfolio mindset: the intellectual shift from managing studies as independent units to managing the portfolio as an interconnected system. This lesson makes that shift operational. You will learn to build the instrument -- the portfolio-level regulatory timeline -- that transforms abstract portfolio awareness into a concrete, readable map of scheduling pressure. The timeline does not tell you what to do. It tells you what is coming and when the work must start, which is the prerequisite for every resource allocation decision you will make.
What you will learn
By the end of this lesson, you will be able to:
Regulatory Coordinator
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