Facilitating Understanding in Informed Consent
Have you read the new draft Guidance from FDA for Sponsors, Investigators and IRBs on Key Information and Facilitating Informed Consent?
Date: October 9, 2024
Time: 12:00 – 1:00 PM ET
Do you use plain language principles when developing an informed consent? Join the live webinar as our speaker discusses this guidance.
Upon completion of this continuing education program, participants should be able to:
- Be familiar with changes made to Common Rule and why FDA has issued a new draft guidance.
- Identify Key Information that might impact a trial participant’s decision on whether to participate and approaches to presenting information.
- Learn what FDA recommends on organizing and presenting information to facilitate understanding.
Speaker:
Brigid Flanagan, BA, RN, MSB, MRQA
Managing Director
Oriel Research Services
Brigid Flanagan BA, RN, MSB, MRQA, is a research professional with 20+ years’ experience in clinical operations. Brigid has been an active member of ACRP since 1998 and served on their Professional Ethics Committee for 5 years. She has presented at ACRP, SCOPE, MAGI and the European Clinical Quality Forum. She currently leads the Site Quality workstream at WCG Avoca Quality Consortium.
Approved for 1.0 ACRP Contact Hours