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Clinical Research Coordinator Analysis

Day 1 Visit Logistics and Participant Burden

Finding: The protocol's Schedule of Activities (Appendix 1) and Section 6.2.3 mandate multiple pharmacokinetic (PK) samples on Day 1: pre-dose, and at 2, 4, and 8 hours post-first-dose of Investigational Product. This necessitates participants remaining at the clinical site for an extended period, likely exceeding 8-9 hours when considering the other Baseline/Randomization procedures. This presents a significant logistical challenge for site resource allocation (e.g., dedicated participant space, extended staff availability) and imposes a considerable time burden on participants on an already procedure-intensive visit day. Recommendation: To effectively manage this, site staff should proactively develop a detailed Day 1 operational plan. This plan should include: 1. Explicitly communicating the full Day 1 time commitment (estimated at 8-9+ hours) to potential participants during the informed consent process, ensuring they understand and can accommodate this extended visit. 2. Strategically scheduling Day 1/Randomization visits to begin as early as possible in the morning to ensure all procedures, including the final 8-hour PK draw, can be completed within the site’s standard operational hours and by appropriately trained staff. 3. Designating a comfortable, quiet, and private area where participants can wait between procedures and PK draws. 4. Creating a "Day 1 Visit Kit" that includes all necessary supplies, pre-labelled PK tubes for each timepoint, source document templates, and participant comfort items (e.g., water, snacks, Wi-Fi access information if available) to streamline workflow and enhance the participant experience. Rationale: Implementing these proactive planning measures will help manage participant expectations, improve participant retention by minimizing undue burden, reduce the risk of missed PK samples or protocol deviations related to visit timing, and ensure efficient utilization of site staff and resources on this critical study visit.