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Clinical Research Coordinator Analysis

eDiary Data Flow and Source Documentation

Finding: The protocol specifies the use of an electronic diary (eDiary) for daily pain intensity and rescue medication reporting (Section 7.1.1.1) and an Electronic Data Capture (EDC) system for overall data collection (Section 10.1). However, there is a lack of explicit detail regarding the data flow mechanism between the eDiary platform and the EDC system (e.g., direct integration vs. manual transcription by site staff). Furthermore, the protocol does not clearly define what constitutes the official source document for the eDiary-collected data, which is crucial for site record-keeping and audit preparedness. Recommendation: We recommend the Sponsor provide a supplementary document (e.g., a study-specific Data Management Plan excerpt or a Site Operations Manual section) that clearly outlines: 1. The step-by-step process for how eDiary data is transferred to or reconciled with the EDC. 2. Whether site staff are responsible for manual transcription of eDiary data into the EDC or if it's an automated/verified import. 3. The definitive source documentation requirements for eDiary entries (e.g., if the eDiary system itself is the source and accessible for SDV, or if certified printouts/reports are required for the Investigator Site File). 4. Procedures for sites to monitor eDiary compliance and manage/document any discrepancies or missing eDiary data. Rationale: This clarification will enable sites to accurately plan CRC workload for data entry and management, ensure consistent data handling practices across all sites, minimize the risk of transcription errors if manual entry is involved, and ensure robust, compliant source documentation for participant-reported outcomes collected via the eDiary, thereby strengthening data integrity and audit readiness.