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Clinical Research Coordinator Analysis

Visit Procedures and Participant Preparation

Finding: The protocol (Table 5-1, Schedule of Assessments, footnote 'c', page 42) mandates fasting (nothing to eat or drink except water for at least 8 hours prior to blood draw) for lipid panel and glucose at multiple key study visits (Baseline, Week 4, Week 16, Week 32, Week 52, and Early Termination). These visits often involve other lengthy procedures and assessments, potentially increasing participant burden and the risk of non-compliance with fasting instructions, which could impact lab data validity. Recommendation: For robust operational planning, sites should:

1. Develop and implement a standardized site process for proactively communicating fasting requirements to participants multiple times before each applicable visit (e.g., at scheduling, via reminder calls/messages).

2. Prioritize scheduling these specific visits in the early morning slots where feasible, to make fasting more manageable for participants.

3. Incorporate a consistent source documentation method to clearly record the participant's fasting status, including the time of last food/drink intake, at each relevant visit prior to blood collection.

4. Inquire with the Sponsor/CRO if standardized, patient-friendly reminder cards or digital notifications regarding fasting could be provided to sites for distribution to participants.

Rationale: Implementing these proactive measures will help optimize participant adherence to critical pre-procedure requirements, thereby ensuring the integrity and reliability of key laboratory safety data (lipids, glucose), reducing the likelihood of visit delays or rescheduling, and minimizing the potential for protocol deviations related to incorrect fasting status.