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.
Released on: November 7, 2019
Topics: I) Regulatory Challenges for Decentralized Clinical Trials, II) Revised Common Rule