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Clinical Research Coordinator Analysis

Screening Procedures & Eligibility Verification

Finding: The protocol mandates Child-Pugh Class A liver function (Inclusion Criterion #5, p.28), and a footnote specifies that the "Child-Pugh score must be calculated and recorded in source documents at screening." While individual components (bilirubin, albumin, PT/INR, ascites, encephalopathy) are collected as per the Schedule of Assessments (SoA, p.36), there's a potential operational gap in ensuring the *aggregate score calculation* itself is consistently performed, documented, and verified by the investigator specifically at the screening stage, prior to any treatment decisions or randomization. Recommendation: Implement a dedicated section or checklist item within the site's screening source document template that explicitly requires the documentation of the calculated Child-Pugh score and its classification (A, B, or C). This section should also include a space for PI/Sub-I signature specifically confirming the score and eligibility based on this criterion before the participant is deemed fully eligible and proceeds to Cycle 1 Day 1. Rationale: This proactive documentation step ensures adherence to a critical inclusion criterion, minimizes the risk of enrolling ineligible participants due to an overlooked or miscalculated score, and improves audit readiness by having clear, investigator-verified source data for this specific eligibility component.