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Clinical Research Coordinator Analysis

eDiary Data Review and Exacerbation Identification

Finding: The protocol (Section 6.4.1) states site staff will review eDiary data "regularly" to identify suspected COPD exacerbations, which are defined by symptoms lasting "at least 2 consecutive days" (Section 7.6). The term "regularly" lacks specific definition, creating a risk of inconsistent review frequency across staff or over time. This ambiguity could lead to delays in identifying exacerbations that meet the 2-day criterion, potentially impacting timely participant management, scheduling of Unscheduled Visits (UAVs), and the accuracy of capturing exacerbation start dates crucial for endpoint analysis. Recommendation: For operational planning, the site should establish and document a specific minimum frequency for eDiary review (e.g., daily on business days). This should be incorporated into the site's study-specific work instructions or SOPs. Additionally, participants should be explicitly instructed during eDiary training to proactively contact the site study team if they experience worsening symptoms indicative of a potential exacerbation, rather than solely relying on site-initiated contact following eDiary review. Rationale: This approach ensures more consistent and timely identification of potential COPD exacerbations, facilitates prompt clinical assessment and appropriate management (including UAV scheduling), improves data quality and integrity for key exacerbation endpoints, and supports proactive participant safety monitoring.