21 August 2026
Rethinking risk-based monitoring in early phase clinical trials
Rethinking risk-based monitoring in Early Phase clinical trials
Early phase clinical trials, especially first-in-human (FIH) studies, have long defaulted to 100% source data verification (SDV) as a safeguard for participant safety and data integrity. But as trial complexity increases and digital tools reshape oversight capabilities, how we ensure participant safety and data integrity also needs to evolve, begging the question: Is full SDV really needed, or could smarter oversight strategies achieve the same, or better, outcomes?
This paper is a review of SDV and targeted SDV (tSDV), a risk-based monitoring method typically reserved for later phase studies, as well as their benefits, risks, and regulatory considerations. It also explores one sponsor’s decision to implement tSDV in an early phase trial, using it as a working example of what’s possible when contract research organizations (CROs) and sponsors work collaboratively to challenge assumptions in the quest to ensure participant safety and data integrity while taking a thoughtful risk-based approach to clinical trial oversight.
We’re not here to declare tSDV is the future of Phase I. Instead, we aim to open the conversation by sharing what we learned, highlighting what still needs further investigation, and inviting you to consider how oversight strategies can evolve.
