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Clinical Research Coordinator Analysis

Visit 2 (Day 1) Procedures & Participant Burden

Finding: The protocol (Section 7.3.3, Page 46) mandates a pharmacokinetic (PK) blood sample at Visit 2 (Day 1) "approximately 4 hours (±1 hour) postdose" of the first study intervention. This will significantly extend the Day 1 visit duration for participants (potentially 5-6 hours total, encompassing pre-dose assessments, dosing, and the 3-5 hour post-dose waiting period), posing a logistical challenge for the site and a considerable time commitment for participants. Recommendation: Sites should proactively plan for this extended Day 1 visit by: 1. Clearly and transparently communicating the expected visit duration and the reason for it (PK sample) to potential participants during the informed consent discussion and in appointment confirmations. 2. Allocating appropriate clinic resources, such as a comfortable and quiet waiting area for participants during the post-dose period. 3. Strategically scheduling Day 1 visits to manage clinic flow and ensure staff availability for both the initial procedures and the timed post-dose PK draw. Rationale: Improves participant understanding and satisfaction by managing expectations upfront, reduces the likelihood of missed PK samples due to participant inconvenience or surprise, and enables smoother site operations and resource management for this critical first treatment visit.