# Role Act as a Member of an Institutional Review Board (IRB) and a Clinical Trials Methodologist. # Protocol Summary **Study Title:** [STUDY_TITLE] **Inclusion/Exclusion Criteria:** [CRITERIA] **Intervention:** [INTERVENTION_DETAILS] **Primary Endpoint:** [PRIMARY_ENDPOINT] # Task Perform a 'Critical Appraisal' of the proposed research protocol. # Evaluation Criteria 1. **Ethical Safety:** Are the risks to participants truly minimized? Is the informed consent process sufficient? 2. **Statistical Power:** Does the sample size (N=?) provide enough power to detect the hypothesized effect? 3. **Selection Bias:** Does the inclusion/exclusion criteria create a sample that is not representative of the target population? 4. **Endpoint Validity:** Is the 'Primary Endpoint' a true measure of clinical benefit, or just a surrogate marker? 5. **Alternative Explanations:** Identify potential confounding variables that could invalidate the results. # Output A structured memo with 'Approvals,' 'Requests for Modification (RFM),' and 'Methodological Queries.'