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Site Management Flashcards

6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. What is the purpose of a site initiation visit (SIV) in clinical research?

    Answer: To train site staff on the protocol, procedures, and regulatory requirements before study initiation

    The SIV is conducted by the sponsor/CRO before enrollment to ensure site staff are trained on the protocol, CRF completion, safety reporting, and study-specific procedures.

  2. What is a 'delegation log' (also called a 'delegation of authority log') at a clinical trial site?

    Answer: A document identifying each staff member's qualifications and the specific trial tasks they are authorized to perform

    A delegation log records each study team member's qualifications (CV, training) and the specific tasks they are authorized to perform, signed by the PI.

  3. What is the role of a Clinical Research Coordinator (CRC)?

    Answer: To coordinate day-to-day trial activities, support subject visits, maintain regulatory documents, and ensure protocol compliance

    The CRC manages the operational aspects of clinical trials including subject coordination, regulatory document maintenance, data collection, and communication with sponsor and IRB.

  4. What must be verified during a site feasibility assessment?

    Answer: Site's patient population, staff qualifications, facilities, regulatory experience, and competing studies

    Site feasibility assesses the available patient population, investigator and staff qualifications and experience, facilities, equipment, and competing workload.

  5. What is the purpose of a 'close-out visit' at the end of a clinical trial?

    Answer: To reconcile trial supplies, ensure records are complete, archive documents, and confirm all outstanding issues are resolved

    The close-out visit ensures all unused drug is reconciled and returned, all essential documents are archived, outstanding data queries are resolved, and the site is properly closed.

  6. What is meant by 'subject recruitment and retention' strategies in clinical trial site management?

    Answer: Planned approaches to identify, enroll, and keep subjects participating throughout the trial

    Recruitment strategies identify eligible subjects and motivate enrollment, while retention strategies reduce dropout through follow-up reminders, visit flexibility, and participant engagement.