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Clinical Research Coordinator Analysis

Subject Diary Data Collection and Management

Finding: The protocol (Section 7.3.2) specifies the use of paper diaries for subjects to record daily IP administration, daily concomitant medications, and any AEs. This information is then to be transcribed into the eCRF by site staff. This approach carries a high risk of incomplete or inaccurate data due to potential participant non-compliance with daily entries (leading to recall bias) and is prone to transcription errors by site staff, significantly increasing the potential for data queries and site workload. Recommendation:

1. Strongly recommend that the Sponsor explore and provide an electronic diary (eDiary) or ePRO (electronic Patient-Reported Outcome) solution. This would enable direct data capture, potentially include reminders for participants, reduce transcription errors, and streamline data integration into the EDC.

2. If paper diaries remain the sole method, the site should develop and implement a standardized, meticulous diary review checklist to be used with the participant at each visit. This checklist should include specific probing questions to aid recall and ensure completeness of IP administration records, concomitant medications, and AE reporting. Enhanced, clear participant training on the critical importance of contemporaneous diary completion and immediate reporting of any new health concerns to the site (rather than waiting for the next visit) should also be provided.

Rationale: Implementing an eDiary or a more structured paper diary review process aims to significantly improve the accuracy, completeness, and timeliness of critical participant-reported data, reduce the site's administrative burden associated with manual transcription, minimize data queries, and potentially allow for more prompt identification and management of adverse events.