Regulatory Coordinator

Full course · Safety Reporting Coordination

Supporting the investigator's safety assessment: what information they need and when they need it — Safety Reporting Coordination

Supporting the investigator's safety assessment: what information they need and when they need it

Coordinate the information package the investigator requires for safety assessment, build a pre-assessment verification checklist, and analyze common coordination failures that produce uninformed medical judgments.

22 min

The assessment the investigator almost got wrong

A principal investigator sits down to review a serious adverse event report. A participant in a Phase III trial experienced acute hepatic failure -- transaminases elevated to 15 times the upper limit of normal, bilirubin rising, the patient now hospitalized and under the care of a hepatologist. The investigator must determine causality: is this event related to the study drug? And expectedness: is hepatic failure listed in the Reference Safety Information as a known risk?

The investigator opens the Investigator's Brochure on file. The RSI section lists nausea, elevated transaminases, and headache as identified risks. Hepatic failure is not listed. The investigator is about to record a causality assessment of "possibly related" and an expectedness determination of "unexpected" -- which would trigger a cascade of regulatory reporting obligations, including SUSAR notification to the sponsor and unanticipated problem reporting to the IRB.

But here is what the investigator does not know: three weeks ago, the sponsor distributed an updated IB. Version 12 replaced Version 11. The new RSI section -- Section A.1.2 of Appendix A, the section that defines which adverse reactions are identified risks of the investigational product -- now includes hepatotoxicity, including hepatic failure, based on emerging data from other sites. The updated IB was received at the site. It was logged in the intake system. But the investigator never acknowledged receipt, never reviewed the new RSI, and is now about to make a medical judgment using outdated safety information.

The expectedness determination will be wrong. Not because the investigator lacks medical competence, but because the investigator lacks current information. And that -- the gap between what the investigator knows and what the investigator needs to know -- is the RC's problem to solve.

What you will learn3 objectives

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

Coordinate the information package the investigator needs for safety assessment, including current IB RSI, relevant sponsor communications, site AE history, and cross-study signals -- ensuring delivery before the assessment deadline
Design a pre-assessment information checklist the RC uses to verify the investigator has received all relevant safety data before making causality or expectedness determinations
Analyze common coordination failures that result in uninformed investigator assessments and design preventive controls for each

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The assessment the investigator almost got wrong