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Clinical Research Coordinator Analysis

FDA-PRO Daily eDiary Collection

Finding: The protocol (Section 6.7, page 42) mandates daily eDiary completion of FDA-PRO items (stool frequency, rectal bleeding, abdominal pain, bowel urgency) for the 7 consecutive days prior to the Baseline/Day 1 visit and the Week 2, 4, 8, and 12 visits. While the protocol states "Site staff will be responsible for training participants on the use of the ePRO device/application and for monitoring compliance with eDiary entries," it lacks specific operational guidance on managing and documenting instances of participant non-compliance (e.g., missed days, late entries, partial entries) or technical difficulties encountered by participants with the eDiary device/application. This ambiguity presents a challenge for site staff in consistently enforcing and documenting compliance, potentially leading to increased data queries and variability in data quality for these key outcome measures. Recommendation: Develop and provide sites with a clear, concise eDiary Management Guide. This guide should include:

1. Defined daily entry windows (e.g., entries for Day X must be completed between 00:00 and 23:59 on Day X).

2. Step-by-step instructions for site staff on how to proactively monitor compliance (e.g., daily/bi-daily checks via a site portal, if available).

3. Standardized procedures for addressing non-compliance, including templated participant reminders and re-education talking points.

4. Specific instructions on how to document missed entries, reasons for non-compliance (e.g., participant forgot, technical issue, felt too unwell), and any troubleshooting steps taken by site staff in the source documents and EDC system.

5. Clarification on whether any retrospective data entry is permissible if a participant misses a day due to unavoidable circumstances (and if so, the exact procedure and time limits).

Rationale: Providing clear, actionable guidance on eDiary management will empower site staff to proactively support participants, ensure consistent handling of compliance issues across all sites, reduce the likelihood of missing critical PRO data, minimize data queries, and ultimately enhance the integrity and reliability of the data collected for primary and secondary endpoints.