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Regulatory Coordinator5 of 6
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Module 1: Lesson 1
Timing and responsibility: which records are needed at which trial phases, and who generates them
Establishes the temporal dimension of essential record generation across trial phases for the RC managing records infrastructure across studies simultaneously in different lifecycle phases.
Eighteen studies, three phases, one infrastructure
Picture the following situation -- and if you have worked at a multi-study site for more than a year, you will not need to imagine it, because you have lived it. The site is running 18 active clinical trials. Three are in start-up: regulatory submissions are pending, site initiation visits are being scheduled, and the records that must exist before any participant is enrolled are being assembled. Twelve are in active conduct: data is flowing, monitoring visits are occurring, amendments are being processed, and the volume of records being generated daily is substantial. Three are approaching close-out: final monitoring visits are complete or imminent, databases are being locked, and the records that must exist for archiving are being compiled.
Each of these 18 studies is generating essential records. But here is the infrastructure problem that this lesson addresses: the types of records being generated, the urgency with which they must be captured, and the parties responsible for producing them differ systematically by trial phase. A records infrastructure designed as though all records arrive at the same pace, from the same sources, with the same criticality, will fail under this kind of portfolio load. It will miss pre-study records that should have been in place before enrollment began. It will lose track of sponsor-generated records that arrive during conduct but are not filed because nobody was watching for them. It will discover at close-out that records the investigator needed to retain were never transferred from the sponsor.
This lesson introduces the temporal dimension of essential record management -- the dimension that Lessons 1 and 2 did not address. Lesson 1 established what qualifies as an essential record under E6(R3). Lesson 2 established how to determine whether a specific record is essential. This lesson asks: when must each record exist, and who is responsible for producing it? And it asks that question not for a single study, but for a portfolio of studies simultaneously traversing different lifecycle phases.
What you will learn
By the end of this lesson, you will be able to:
Regulatory Coordinator
Full course · Essential Records Infrastructure & Document Management