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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 investigational product (IP) accountability at a clinical trial site?

    Answer: Documenting the receipt, storage, dispensing, use, and return/destruction of all investigational product

    IP accountability involves maintaining records of all investigational product received, stored, dispensed to each subject, and returned or destroyed, ensuring complete chain of custody.

  2. What is a 'protocol amendment' and what is required when one is issued?

    Answer: A formal revision to the study protocol that requires IRB review and approval before implementation

    A protocol amendment is a formal written change to the protocol that must be submitted to and approved by the IRB, and updated with regulatory authorities, before implementation.

  3. What is a 'pharmacy manual' and why is it used at clinical trial sites?

    Answer: A document providing site pharmacy staff with instructions for IP storage, dispensing, handling, and accountability procedures

    A pharmacy manual provides study-specific instructions to pharmacists regarding IP storage conditions, reconstitution, dispensing procedures, and accountability requirements.

  4. What does 'subject screening' involve in clinical trial site management?

    Answer: Evaluating potential participants against inclusion/exclusion criteria before enrolling them in the trial

    Subject screening involves assessing candidates against the protocol's inclusion and exclusion criteria, typically including medical history review, physical exams, and lab tests.

  5. What is the purpose of a 'randomization log' at a clinical trial site?

    Answer: To record subjects' random assignment to treatment arms in blinded or open-label trials

    A randomization log records each subject's randomization number and treatment assignment (or blind code), maintaining the integrity of the randomization process.

  6. What is a 'screening failure' in clinical research?

    Answer: A potential participant who was screened but did not meet eligibility criteria and was not enrolled

    A screening failure is a subject who was consented and screened for a trial but did not qualify for enrollment based on inclusion/exclusion criteria.