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Clinical Research Coordinator Analysis

Screening Visit ECG Procedures and Eligibility

Finding: The protocol mandates central ECG reading for eligibility determination at Screening (Visit 1, Section 6.3.5), with specific ECG parameters serving as exclusion criteria (Section 4.2.4, e.g., QTcF limits, LBBB, AV block). The operational challenge lies in the potential delay between local ECG acquisition and the availability of the official central ECG read required to confirm eligibility. The protocol does not specify the expected turnaround time for these central readings, which could impact the 42-day screening window, participant scheduling, and overall screening efficiency if there are significant lags. Recommendation: We recommend proactively discussing with the Sponsor/CRO the expected standard turnaround time for central ECG results from the vendor. Sites should then incorporate this timeframe into their screening visit workflow, perhaps by scheduling the screening ECG as early as feasible within the 42-day window. It would also be beneficial to clarify the process for managing participants whose local ECG readings appear borderline or concerning while awaiting the official central interpretation, and to understand if an expedited review process is available for time-sensitive cases. Rationale: Clarifying and planning for the central ECG review timeline will help streamline the screening process, minimize potential delays in eligibility confirmation, reduce participant burden from extended screening periods or repeat visits, and decrease the risk of screen failures due to exceeding the screening window, ultimately supporting more efficient enrollment.