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Clinical Research Coordinator Analysis

PK Sample Collection Visits (Day 1, Week 4, Week 12)

Finding: The protocol (Section 8.2.2.1, Pharmacokinetic Assessments) mandates PK blood collection at pre-dose, 2 hours post-dose, and 4 hours post-dose on Day 1 (Visit 2), Week 4 (Visit 5), and Week 12 (Visit 9). This significantly extends these visit durations to over 4 hours post-dose administration, posing a considerable burden on participants and requiring careful site resource allocation for staffing and space. Recommendation: For site-level operational planning, it is crucial to proactively develop a detailed workflow for these extended PK visit days. This should include: 1) Clearly communicating the extended time commitment to potential participants during the consenting process. 2) Scheduling these participants to allow for dedicated staff attention without impacting other concurrent clinic activities. 3) Designating a comfortable, semi-private waiting area for participants between draws. 4) Preparing "PK visit kits" with necessary supplies in advance. 5) Considering the provision of light refreshments or meal vouchers for participants due to the extended duration. Rationale: Proactive planning and transparent communication will enhance participant understanding, satisfaction, and compliance with these lengthy procedural days, thereby reducing the risk of missed PK samples or participant dropout due to inconvenience. It also ensures efficient use of site resources and minimizes disruption to overall clinic flow.