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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 · Safety Reporting and Pharmacovigilance for CRCs
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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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Process IB amendments using a structured workflow that ensures safety-relevant changes trigger appropriate downstream actions including consent updates, expectedness reclassification, and monitoring adjustments.
A courier package arrives at the site on a Tuesday morning. Inside: Investigator's Brochure, Edition 7, Amendment 2, dated 15 March 2026. The cover letter is two pages. The first paragraph is standard distribution language. The second paragraph is not.
"Section 5.3 (Reference Safety Information) has been updated to include hepatotoxicity as a known adverse reaction. Three confirmed cases of drug-induced liver injury have been reported across the clinical development program, including one case of Hy's Law that required liver transplantation."
The coordinator reads the letter again. Hepatotoxicity is new. It was not in the previous IB edition. The study has 14 currently enrolled participants, three of whom reported mildly elevated transaminases at their last study visit -- events that were documented, graded, and reported to the sponsor as unexpected findings because the prior IB did not list hepatotoxicity as a known reaction.
That word -- "unexpected" -- is about to change. With this IB amendment, hepatotoxicity is now a recognized adverse reaction of the investigational product. Future transaminase elevations may be classified differently. But there is more: every currently enrolled participant signed a consent form that does not mention liver injury as a risk. And the study's monitoring plan does not include the hepatic function panels that the new safety profile would warrant.
This is not a document to file. This is a document to act on.
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