Ensuring Participant Eligibility Sponsor Oversight & Best Practices

Hillary explained that eligibility is reviewed for each patient and that an internal adjudication process is in place when disagreements arise regarding eligibility. While this process is not governed by a formal SOP, it is communicated to sites during Site Initiation Visits (SIVs) and is discussed with the CRO and medical team.

Susan Doleman described a process in which sites complete an eligibility checklist and submit a form along with de-identified source documentation. The sponsor reviews the submitted materials to confirm that patients meet protocol-defined eligibility criteria and provides written confirmation to the site when there is agreement with the site’s assessment.

Kristina noted that her organizations have used similar approaches and acknowledged that sponsors have historically received feedback regarding excessive involvement in patient eligibility decisions. However, she observed that regulatory and industry perspectives have evolved, particularly in studies with more subjective endpoints. She shared positive feedback received from the MHRA regarding a process in which the site and Principal Investigator (PI) perform the initial eligibility assessment, followed by review from the CRO Medical Monitor. Questions may be raised to ensure the PI has conducted appropriate due diligence, but the final enrollment decision remains with the PI. The MHRA viewed the additional review as a valuable independent assessment rather than sponsor interference.

Susan Butler expressed a preference against extensive eligibility checklists and described a process that received favorable audit feedback. Her team conducts regular PI calls to discuss upcoming patients, clarify eligibility requirements, and address challenging enrollment scenarios. For larger studies, IVRS/IWRS tools are also used to capture responses to key eligibility parameters and allocate study slots. Screening information is entered into the EDC and reviewed as part of the enrollment process, although potential participants are often discussed during PI calls beforehand. This approach helps ensure investigators fully understand protocol requirements and can also identify areas where protocol clarification may be needed. Susan noted that her team relies primarily on EDC data rather than collecting source documents.

In contrast, both Susan Doleman and Kristina indicated a preference for reviewing selected de-identified source documentation to verify certain eligibility criteria. Kristina recommended the use of secure portals for sharing de-identified source documents and referenced a platform previously offered by Simulation Plus that was recently acquired by another company.

The discussion also addressed strategies for identifying professional research participants. Hillary highlighted the importance of using available participant-tracking databases to identify individuals who may be enrolled in multiple studies and to assist sites in monitoring medication histories and washout periods.

Finally, Ken noted that his organization utilizes a CRO-managed platform for submission and review of eligibility documentation rather than relying on email communications, providing a more structured and traceable process.