Regulatory Compliance & Guidelines Flashcards
7 cards from real CRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Guidelines flashcards as text
A researcher wants to conduct a retrospective chart review using de-identified patient records at a hospital. Which of the following is most accurate regarding IRB oversight?
Answer: The research may qualify for exemption if data cannot be linked back to individuals
Retrospective chart reviews using truly de-identified data may qualify for IRB exemption because de-identified data does not meet the definition of human subjects research under 45 CFR 46.
Which of the following best describes a 'minimal risk' study under the Common Rule (45 CFR 46)?
Answer: The probability and magnitude of harm are not greater than those encountered in daily life or routine physical/psychological examinations
The Common Rule defines minimal risk as research where the probability and magnitude of harm are not greater than those ordinarily encountered in daily life or routine examinations.
Under HIPAA, which of the following is NOT one of the 18 identifiers that must be removed to create a de-identified dataset under the Safe Harbor method?
Answer: Participant's research ID number assigned by the study team
Research ID numbers assigned by the study team are not PHI identifiers under HIPAA's Safe Harbor method; the 18 identifiers include account numbers, SSNs, and medical record numbers but not arbitrary study codes.
A clinical trial sponsored by a pharmaceutical company is underway. The FDA inspects the site and finds that the investigator failed to follow the protocol. Under 21 CFR Part 312, what action can FDA take?
Answer: Disqualify the investigator from receiving investigational drugs
Under 21 CFR Part 312.70, FDA can disqualify a clinical investigator who has repeatedly or deliberately failed to comply with regulatory requirements.
Which element of informed consent is required under 45 CFR 46.116 but is often misunderstood as optional?
Answer: A statement that participation is voluntary and refusal involves no penalty
45 CFR 46.116 explicitly requires that consent documents state participation is voluntary and that refusal or withdrawal will involve no penalty or loss of benefits.
What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To independently monitor accumulating data and recommend stopping or modifying the trial if safety concerns arise
A DSMB independently reviews accumulating trial data to protect participant safety and may recommend halting or modifying a study if risk-benefit balance shifts unfavorably.
Under the FDA's regulations for Institutional Review Boards (21 CFR Part 56), how often must an IRB conduct continuing review of approved research?
Answer: At least once per year, or more frequently if specified by the IRB
21 CFR Part 56 requires IRBs to conduct continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year.