GCP & Pharmacovigilance Compliance Symposium | D3S03-1 - (BE): Clinical Study Conduct

This session provided understanding of the FDA Bioresearch Monitoring (BIMO) Program and outlined source documentation requirements for determining subject eligibility, including concerning trends observed during inspections. The presentation explained content requirements for informed consent forms (ICF) and identified concerning trends in ICF compliance to support proper clinical trial conduct in bioequivalence studies.

Timestamps

03:45 – FDA Bioresearch Monitoring Compliance Programs

06:45 – Concerning Trends Regarding Documentation and Subject Eligibility

11:28 – Concerning Trends of Informed Consents

15:01 – MHRA bioequivalence (BE) inspections

17:27 – Clinical pathology laboratories

24:44 – Computerized Systems

28:47 – Facilities, Equipment, Electronic Archiving, and Insurance

32:35 – Transparency

Moderator:

Jason Wakelin-Smith, BSc
Expert Good Clinical Practice (GCP) Inspector and
Head of the Compliance Expert Circle
MHRA

Speakers:

Doug Pham, JD, PharmD
Associate Director
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER) | FDA

Emma Whale, MSc
Senior GCP & GLP Inspector
MHRA

Learn more at: https://www.fda.gov/drugs/news-events...

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