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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. Which US federal regulation governs the protection of human subjects in research conducted or supported by federal departments?

    Answer: 45 CFR Part 46

    45 CFR Part 46, known as the Common Rule, is the federal regulation governing protection of human subjects in federally funded research.

  2. What is the primary purpose of 21 CFR Part 312 in clinical research?

    Answer: To establish requirements for Investigational New Drug (IND) applications

    21 CFR Part 312 establishes FDA requirements for IND applications, including sponsor and investigator responsibilities.

  3. Which ICH guideline defines Good Clinical Practice (GCP) standards internationally?

    Answer: ICH E6

    ICH E6 (R2) is the international GCP guideline that establishes standards for the design, conduct, and reporting of clinical trials.

  4. A Form FDA 1572 is required to be signed by which individual?

    Answer: The Principal Investigator

    Form FDA 1572 is the Statement of Investigator that must be signed by the Principal Investigator, committing to GCP compliance.

  5. Under FDA regulations, how long must an investigator retain clinical trial records after the investigation is discontinued or completed?

    Answer: 3 years

    Per 21 CFR Part 312.62, records must be retained for 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued.

  6. What does 'regulatory binder' typically contain at a clinical research site?

    Answer: Essential documents required by ICH GCP and FDA regulations

    The regulatory binder contains essential documents such as the protocol, IND, IRB approvals, CVs, lab certifications, and FDA 1572 required by GCP.