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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Clinical Research Coordinator
Full course · Monitoring, Close-Out & the Modern CRC
Free Lesson Preview
The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
View enrollment optionsAlready enrolled? Sign in
Prepare study documents for long-term archiving by organizing materials systematically, creating comprehensive indices, ensuring physical integrity of paper records, and packaging materials for secure off-site storage.
The retention period has been determined. Perhaps it is 15 years. Perhaps it is 25. Perhaps, for a drug that never reached the market, it remains effectively indefinite. Whatever the duration, the question that matters now is not how long but how well.
There is a difference -- a profound difference -- between storing documents and archiving them. Storing documents means putting them somewhere. Archiving means preparing them so that any specific document can be located, retrieved, and read years or decades after the last person who remembers the trial has moved on. The investigator who signed those consent forms may have retired. The coordinator who filed every query response may now work three states away. The monitor who reviewed those source documents at the last visit may have left the industry entirely. And yet, when an FDA inspector arrives in 2041 and requests the informed consent form for participant 037, someone must be able to find it. Not eventually. Not after searching through 40 unmarked boxes. Promptly.
This is the work we address in this lesson. It is not glamorous work. It does not appear on conference agendas. But I have watched sites lose weeks -- and, on one memorable occasion, face a regulatory citation -- because records that had been "stored" could not actually be retrieved. The time you invest in proper archiving preparation pays for itself the first time someone needs to find something.
Progress saves itself — finish reading and this lesson completes