Investigator Oversight in Decentralized Trials: New Resources and Practical Tools

The Investigator Oversight in Decentralized Trials project builds on the MRCT Center and Medable's prior IRB/EC Considerations for DCT Review. As data capture and trial activities increasingly occur outside traditional trial sites, the characteristics of decentralized trial conduct have created uncertainty about Investigator oversight and how it should be structured when the PI has no supervisory or contractual role with others collecting data and conducting trial activities.

To help close that gap, the MRCT Center and Medable developed four new resources for investigator oversight in clinical trials with decentralized elements (DCTs), with input from the Investigator Oversight in DCT task force. These resources include a proportional oversight framework, an approach to optimize DCT elements, a model instruction sheet for local healthcare providers, and a set of illustrative scenarios covering roles and responsibilities in common clinical situations from withdrawal requests to serious adverse events.

On Thursday, September 24, 2026, from 12:00 PM – 1:00 PM ET, the MRCT Center and Medable will host a webinar to release the resources and walk through their intended use and how they fit together.