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Clinical Research Coordinator Analysis

Pharmacokinetic Sample Collection Timing

Finding: Section 7.4.1 (Pharmacokinetics) states that blood samples for AZD1234 plasma concentrations will be collected "predose (within 2 hours before dosing) and at specified time points postdose at the visits specified in the SoA." However, the Schedule of Assessments (Table 1) only indicates "Pharmacokinetics (PK) sample collection" without detailing the specific post-dose time points (e.g., 1 hour, 4 hours post-dose). This lack of specificity makes it challenging to accurately plan participant visit duration, allocate nursing resources for timed draws, and ensure adherence to precise collection windows. Recommendation: Proactively request immediate clarification from the Sponsor/CRO regarding the exact post-dose PK sampling time points and their acceptable windows (e.g., 2 hours +/- 10 minutes post-dose administration of IP). Once this information is received, incorporate these specific timings into site-specific visit checklists and clearly communicate them to all staff involved in participant visits and IP administration to ensure synchronized activities. Rationale: Clarifying these time points upfront is crucial for minimizing the risk of protocol deviations related to missed or out-of-window PK samples, ensuring the integrity of valuable pharmacokinetic data, and facilitating efficient clinic workflow and resource management on busy clinic days.