Interesting comments on FDA AE Draft Guidance

Here are some interesting comments on the FDA Draft Guidance “Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs – Improving Human Subject Protection” by my friend Erica Heath, President of IRC-IRB. She points out that IRBs need unexpected problems reported as well as AEs. She notes that “all AEs are problems but not all problems are AEs.” Recommended reading in all your spare time:


Read additional posts on Good Clinical Practice- GCP:

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