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Clinical Research Coordinator Analysis

PK Sample Collection & Processing Logistics

Finding: The intensive Pharmacokinetic (PK) sampling schedule (Protocol Section 7.6, Schedule of Assessments Table 2), requiring precisely timed blood draws (pre-dose; 1, 2, 4, 8, 12, 18, 24 hours during infusion; and 1 hour post-infusion) and subsequent specific, time-sensitive processing (centrifugation, aliquoting, freezing at -70°C) for critically ill ICU patients, presents a significant logistical challenge. This is particularly concerning for samples due during night shifts, weekends, or holidays, potentially increasing the risk of missed collections, timing deviations, or processing errors if relying solely on busy ICU clinical staff or requiring constant on-call research personnel. Recommendation:

1. During site initiation, seek clarification from the Sponsor regarding acceptable timing windows for PK collections (e.g., ±10-15 minutes for specific timepoints) without impacting data integrity.

2. Inquire if temporary refrigerated storage (2-8°C) of whole blood samples for a short, validated period (e.g., up to 1-2 hours) prior to centrifugation and processing is permissible. This could allow for batch processing by research staff during more feasible hours for some overnight samples, reducing immediate burden.

3. Develop a detailed, site-specific 24/7 Standard Operating Procedure (SOP) or workflow for PK sample management. This should include:

* Clear delineation of responsibilities between research staff and ICU nursing staff (if any tasks are delegated).

* An on-call schedule for trained research personnel.

* Preparation of pre-labeled, timepoint-specific PK collection kits containing all necessary supplies to streamline the process at the bedside.

* Contingency plans for unexpected delays or issues.

4. Conduct comprehensive, hands-on training for all involved personnel, emphasizing the critical nature of collection times and processing steps.

Rationale: Proactive clarification of timing flexibility and development of robust site-specific logistical plans will significantly improve the feasibility of obtaining high-quality, evaluable PK samples. This approach aims to reduce the risk of protocol deviations, minimize errors in sample handling, alleviate undue burden on ICU and research staff, and ultimately ensure the integrity of crucial pharmacokinetic data for this study.