The group discussed approaches to patient eligibility review and sponsor involvement in confirming enrollment criteria.

• Eligibility may be reviewed for each patient, with an internal adjudication process used when disagreements arise regarding eligibility. In one approach discussed, the process is not governed by a formal SOP but is communicated to sites during Site Initiation Visits (SIVs) and discussed with the CRO and medical team.
• Another approach involves sites completing an eligibility checklist and submitting 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.
• The group discussed that sponsors have historically received feedback regarding excessive involvement in patient eligibility decisions. Regulatory and industry perspectives may be evolving, particularly in studies with more subjective endpoints.
• A process discussed that received positive MHRA feedback involves the site and Principal Investigator (PI) performing 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 additional review was viewed by the MHRA as a valuable independent assessment rather than sponsor interference.
• Approaches varied regarding the use of extensive eligibility checklists. One process that received favorable audit feedback relies on regular PI calls to discuss upcoming patients, clarify eligibility requirements, and address challenging enrollment scenarios.
• For larger studies, IVRS/IWRS tools may also be used to capture responses to key eligibility parameters and allocate study slots. Screening information can be entered into the EDC and reviewed as part of the enrollment process, although potential participants may be discussed during PI calls beforehand.
• Regular PI discussions can help ensure investigators fully understand protocol requirements and may identify areas where protocol clarification is needed.
• Approaches also varied regarding source documentation. Some members favored relying primarily on EDC data rather than collecting source documents, while others preferred reviewing selected de-identified source documentation to verify certain eligibility criteria.
• Secure portals were recommended for sharing de-identified source documents. A platform previously offered by Simulation Plus and recently acquired by another company was referenced during the discussion.
• The group also addressed strategies for identifying professional research participants. Available participant-tracking databases can help identify individuals who may be enrolled in multiple studies and assist sites in monitoring medication histories and washout periods.
• A CRO-managed platform can also be used for submission and review of eligibility documentation rather than relying on email communications, providing a more structured and traceable process.