Webinar
Presented on: September 24, 2026
The MRCT Center and Medable introduced four tools for proportionate investigator oversight in clinical trials with decentralized elements, developed with the Investigator Oversight in DCT Task Force. Pamela Tenaerts, Chief Medical Officer of Medable, outlined what ICH E6(R3) changes for investigator oversight ahead of Annex 2 taking effect January 15, 2027. Barbara Bierer, Faculty Director of the MRCT Center, walked through how the tools follow a trial from the sponsor’s protocol design to the local healthcare provider (HCP) at the participant visit.
A panel followed on what proportionate oversight means in practice, how to plan local HCP roles early, and how to keep HCPs within their scope while trial decisions stay with the investigator.
- Cheryl Grandinetti, PharmD, Associate Director for Clinical Policy, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, CDER, FDA
- Nicole Stansbury, Senior Vice President of Global Clinical Operations, Premier Research
- Therica Miller, MBA, CCRP, Associate Vice President of Clinical Research Administration, UT Health San Antonio
- Barbara E. Bierer, Faculty Director of the MRCT Center (co-moderator)
- Pamela Tenaerts, Chief Medical Officer of Medable (co-moderator)