Decentralized clinical trials (DCTs) can reduce participant burden and broaden access, but they also raise critical questions about oversight, roles, and responsibilities. Developed by the MRCT Center and Medable, with input from the Investigator Oversight in DCT Task Force, these practical tools help sponsors, investigators, and local healthcare providers (HCPs) apply a risk-proportionate approach to trial oversight. The resources and tools support oversight across decentralized clinical trial activities, from protocol design and site-level oversight to the participant visit itself.
Project background
In May 2023, the U.S. Food and Drug Administration (FDA) released its guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, providing recommendations for the conduct of clinical trials that include decentralized elements.
Shortly after, the MRCT Center and Medable convened a multi-stakeholder discussion to explore the implications of the guidance, with particular focus on investigator responsibilities and oversight in decentralized clinical trials (DCTs). Participants included representatives from the FDA, the Office for Human Research Protections (OHRP), academic institutions, sponsors, and contract research organizations (CROs).
The challenge
As clinical trial activities and data collection increasingly occur outside of traditional research sites, questions emerged regarding the scope and implementation of investigator oversight. Key challenges included:
- Clarifying investigator responsibilities and oversight expectations in decentralized clinical trials.
- Defining how oversight should be implemented when investigators do not have direct supervisory or contractual relationships with individuals conducting trial activities or collecting study data.
- Distinguishing the respective roles and responsibilities of investigators, sub-investigators, delegated study team members, and local healthcare providers involved in trial conduct.
Why This Work Matters
The rapid adoption of decentralized trial approaches has created new opportunities to improve trial accessibility and participant engagement. At the same time, it has introduced uncertainty regarding oversight, accountability, and role delineation. To address these challenges, the MRCT Center and Medable launched a collaborative initiative to develop practical tools and resources that support appropriate investigator oversight in trials with decentralized elements. Together, these tools and resources represent a coherent, integrated system for decentralized trial conduct—sponsor-driven design, investigator-calibrated oversight, HCP-executed delivery, and a clear escalation structure when reality diverges from plan.
Project Tools:
PRACTICAL GUIDE
How These Four Documents Work Together: A Practical Guide for Sponsors, Investigators, and HCPs
We recommend first reviewing our How These 4 Tools Work Together document before accessing the Oversight in DCTs Framework and Tools.
TOOL
Optimizing Decentralized Elements in Clinical Trials (DCTs)
A practical guide to help investigators understand sponsors’ responsibilities when designing and implementing trials with decentralized elements.
TOOL
Proportional Oversight Framework for Clinical Trials with Decentralized Elements
A decision-support framework that helps investigators, sponsors, and other trial stakeholders align investigator oversight with critical-to-quality factors and identified risks in trials with decentralized elements.
TOOL
Clinical Trial Instruction Sheet for Local Healthcare Providers (HCPs)
This model HCP Instruction Sheet is meant to be pre-filled by the sponsor and the site, so the local health provider knows what is being asked of them.
TOOL
HCP Check-In Questions for Participants
A consistent way to ask how a participant is doing between visits, with worked responses to nine situations, ranging from a withdrawal request to adverse events.
Related Events & Resources
Related Webinar(s):
Proportinate Oversight in DCTs Toolkit Launch Webinar | September 24, 2026
COMING SOON — The On-Demand Webinar Recording