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Compliance In Focus
Posted by John Lehmann on Thu, Apr 27, 2017

IRB + 123 = Patient Protection

The key players in a clinical investigation are infamously made up of Sponsors, monitors, IRB 123.jpginvestigative sites, and patients. A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected.” That’s a tall order!

FDA has placed an enormous responsibility on institutional review boards. The rules that govern IRBs are clearly laid out in 21 CFR 56, which contains general standards for IRB:
  1. Composition
  2. Operation
  3. Responsibility

To help all the key players in an investigation better understand the role and responsibilities of an IRB, we’ve put together an infographic cheat-sheet called:

IRB’s 123’s

Check out the infographic and feel free to print our guide as a tool for your entire research team! After all - no matter what position you play on the clinical research team, we’re all responsible for protecting the rights and welfare of human subjects.

Let us know what you think!

ALCOA-C Checklist Download

Topics: Patient Protection, FDA, IRB


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