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Clinical Research Coordinator Analysis

Menstrual Cycle Regularity Assessment

Finding: The protocol mentions "diary completion" (Section 5.2.2) and lists "changes in menstrual cycle regularity" as a secondary outcome (Section 5.3.2). However, it lacks specific guidance on what aspects of the menstrual cycle should be recorded in the participant diary, how "regularity" will be defined for analysis based on these recordings, and how site staff should consistently extract and document this information from the diary or participant report. This ambiguity could lead to inconsistent data collection, variability in how "regularity" is interpreted, and difficulties in accurately assessing this important secondary outcome.

Recommendation: Enhance the protocol or create a supplementary study-specific guidance document to: 1. Clearly define the specific data points for menstrual cycle tracking to be recorded in the participant diary (e.g., start and end dates of menses, character of flow if relevant, presence of spotting). 2. Provide a standardized, operational definition of "menstrual cycle regularity" that will be used for analysis (e.g., based on cycle length parameters, variability over a defined period). 3. Include standardized questions or a structured checklist for site staff to use at follow-up visits when reviewing diary entries with the participant and transcribing data to the CRF, ensuring completeness and accuracy.

Rationale: Implementing these clarifications will significantly improve the quality, consistency, and completeness of data collected for the menstrual cycle regularity endpoint. This proactively reduces the risk of CRF queries, minimizes inter-participant and inter-assessor variability, and ensures that the collected data are robust and reliable for statistical analysis, ultimately strengthening the study's conclusions regarding this secondary outcome.