FDA Regulations
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:
Revised Common Rule Compliance Now in Full Effect—and What That Means
The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.
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