Demonstrating PI Oversight of Data

Overview

PI oversight is intended to focus a clinician’s attention where it matters most: on the data and decisions that affect participant safety and trial quality. As trial complexity has increased, investigators frequently perform oversight activities across multiple systems and large volumes of data, making it harder to distinguish the items that warrant the greatest clinical attention.

Redundant sign-off remains common, including paper source alongside eCRF, and review tends to concentrate at end-of-cycle milestones rather than as data becomes available. Meanwhile, modern trials already generate rich evidence of review through eSource, EDC, safety systems and central monitoring. However, signatures remain the primary way oversight is demonstrated, even when they reflect administrative confirmation more than meaningful review.

Through this initiative, TransCelerate is developing and validating approaches that evidence PI oversight in a way that is proportionate to risk and meaningful in practice, while improving the site experience. Working with sites, CROs, and sponsors, TransCelerate is:

• Characterizing how PI review and attestation work today, including the volume, timing, and variability behind the burden sites describe.
• Exploring alternative artifacts beyond signatures, such as possibly targeted attestations and system-generated audit trails, to support a risk-based approach to evidencing PI oversight.
• Translating learnings into practical guidance sponsors can use to reduce site burden.