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Clinical Research Coordinator Analysis

Pharmacokinetic (PK) Sample Collection on Cycle 1 Day 1

Finding: The PK sampling schedule on C1D1 (pre-dose, 0.5, 1, 2, 4, 6, 8, and 24 hours post-first dose of ST-120, as per Table 4-1) is highly intensive. This necessitates an approximate 8-hour stay for the participant on C1D1 for the initial set of samples, followed by a return visit on what would effectively be Cycle 1 Day 2 for the 24-hour sample. This poses a significant logistical burden for outpatient clinic flow, staffing for precisely timed collections and immediate processing, and can be a substantial burden for participants, especially those who are frail or travel long distances. Recommendation: For site operational planning and to ensure high data quality:

1. The study laboratory manual should explicitly define the acceptable collection time windows for each PK sample (e.g., 0.5hr sample collected at 30 mins +/- 5 mins; 24hr sample collected at 24hrs +/- 1 hr post-dose).

2. Confirm within the protocol or lab manual that the 24-hour post-first-dose PK sample is intended to be collected as an outpatient visit on Cycle 1 Day 2.

3. Strongly advise sites during site initiation visits to pre-allocate dedicated, trained staff (e.g., a specific CRC or research nurse) for C1D1 PK collection days and to block schedule appropriate clinic chair/bed time and lab processing resources well in advance.

4. The lab manual should provide clear, unambiguous, step-by-step sample processing instructions for each timepoint, including clarification on whether samples can be batched for centrifugation or must be processed immediately, to help manage the high volume and rapid succession of samples.

Rationale: Proactive planning based on these detailed clarifications will minimize the risk of protocol deviations related to PK sample timing and collection errors, ensure the integrity and quality of critical PK data, help manage participant expectations and reduce their potential burden, and allow sites to allocate nursing and lab resources efficiently, thereby preventing disruption to other essential clinic activities.