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Part 2: Revised Common Rule and Single IRB (sIRB) Questions - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

November 7, 2019 @ 10:00 am 3:00 pm

Ropes & Gray LLP, Washington, DC

Attendees focused on regulatory ambiguities surrounding sIRB usage as research enterprises prepare to transition to full compliance with the Revised Common Rule. Attendees also addressed interpretations of the phrase ‘key information’ and examined how much authority an IRB retains after designating research for limited review.


Meeting Summary

Released on: November 7, 2019

Topics: I) Regulatory Challenges for Decentralized Clinical Trials, II) Revised Common Rule