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Regulatory Compliance 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.

Read the first 6 Regulatory Compliance flashcards as text

  1. What is the key distinction between a 'sponsor' and an 'investigator' under FDA regulations?

    Answer: The sponsor initiates and oversees the trial; the investigator conducts it at the site

    Under 21 CFR Part 312, the sponsor initiates and takes responsibility for the investigation, while the investigator conducts it at a specific site.

  2. What must a site do when a protocol deviation occurs that increases risk to participants?

    Answer: Report it to the IRB and sponsor promptly

    Protocol deviations that increase risk to participants must be reported promptly to both the IRB and the sponsor per GCP requirements.

  3. Under HIPAA, what does 'minimum necessary' mean in the context of clinical research?

    Answer: Only protected health information needed for the specific research purpose should be accessed

    The HIPAA 'minimum necessary' standard requires that only the PHI needed to accomplish the intended research purpose is used or disclosed.

  4. What is the role of an IRB in the context of an expedited review?

    Answer: Review minimal-risk studies or minor changes to approved research without full board convening

    Expedited IRB review allows a designated reviewer to approve minimal-risk studies or minor protocol changes without convening the full board.

  5. According to FDA regulations, which of the following is NOT required on a Form FDA 1572?

    Answer: The investigator's financial disclosure information

    Financial disclosure is collected on Form FDA 3455/3454, not on Form FDA 1572, which covers investigator commitments and site information.

  6. What is a 'Sponsor-Investigator' in clinical research?

    Answer: An individual who both initiates and conducts a clinical investigation

    A Sponsor-Investigator is an individual who both initiates and conducts an investigation and under whose immediate direction an investigational drug is administered.