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Clinical Research Coordinator Analysis

Visit 3 (Week 1 Phone Call) Procedures

Finding: The Schedule of Activities (Table 10, Section 7.2.3) indicates that Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), and Body Surface Area (BSA) affected by Atopic Dermatitis are to be assessed during Visit 3 (Week 1 ± 3 days). However, Visit 3 is designated as a "Phone Call". These critical efficacy endpoints (IGA, EASI, BSA) are clinician-rated assessments that require direct, in-person visual and often tactile examination of the participant's skin to be performed accurately and reliably. Attempting these assessments via a standard phone call is not feasible and would lead to highly questionable data quality. Recommendation: It is recommended to clarify the modality for these specific assessments at Visit 3. If an early Week 1 assessment of IGA, EASI, and BSA is crucial for the study, Visit 3 should be converted to an in-person visit. Alternatively, if the phone call modality for Visit 3 must be maintained, these specific clinician-rated assessments (IGA, EASI, BSA) should be removed from this visit's schedule or moved to the next in-person visit (Visit 4 - Week 2). If only these assessments require an in-person component, a brief, targeted in-person visit for these specific evaluations could be considered, separate from the main phone contact. Rationale: This clarification is essential to ensure the integrity, validity, and consistency of key efficacy data. Modifying the protocol as suggested will prevent inevitable protocol deviations, reduce site burden and confusion regarding how to conduct these assessments, and ensure that the data collected for these important endpoints are robust and defensible.