Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

Patient Diary Management

Finding: The protocol (Section 6.7) mandates a patient diary for recording GI AEs and flushing (daily for Month 1, then weekly for the study duration up to 96 weeks). However, it lacks crucial operational specifics regarding the diary's format (paper or electronic), the method for integrating diary data into the EDC, and clear, standardized procedures for reconciling diary-reported AEs with those captured via standard AE reporting by the investigator. This ambiguity poses risks for inconsistent data quality, significant unbudgeted site burden for review, potential transcription, and participant compliance challenges over the extended study period. Recommendation: To enhance operational efficiency and data integrity, it is recommended that the Sponsor:

1. Specify the diary format. If electronic (eDiary), provide comprehensive details on the platform, user training for sites and participants, technical support, and data flow/integration with the EDC.

2. If a paper diary is to be used, provide a standardized, user-friendly template. Accompany this with explicit, step-by-step instructions for site staff on reviewing entries, querying discrepancies or omissions with the participant, and a consistent method for transcribing or summarizing this data into the EDC.

3. Develop and disseminate a detailed guidance document or a study-specific addendum to site SOPs. This document should cover:

a. Standardized participant training on accurate and timely diary completion.

b. A systematic process for site staff to review diary entries thoroughly at each study visit.

c. Clear rules for reconciling AEs reported in the diary (e.g., occurrence, severity, duration) with AEs elicited or observed by the investigator, including how to resolve discrepancies and ensure the CRF/EDC accurately reflects the definitive AE information.

d. Proactive strategies for sites to encourage and monitor long-term participant adherence to diary completion.

Rationale: Implementing these recommendations will significantly improve the quality, consistency, and reliability of key tolerability data derived from patient diaries. It will also help manage site workload effectively, reduce the potential for data entry errors or inconsistencies, bolster participant engagement and compliance with diary requirements, and ensure more accurate and comprehensive AE reporting, ultimately strengthening the study's outcomes.