CPI Regulatory Compliance & Ethical Standards 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, what is the maximum timeframe within which an investigator must report an unexpected serious adverse event to the IRB?
- Within 24 hours
- Within 7 calendar days (Correct answer)
- Within 10 working days
- Within 30 days
Correct answer: Within 7 calendar days
Unexpected serious adverse events must be reported to the IRB within 7 calendar days under 21 CFR Part 312.
Question 2: Which ethical principle from the Belmont Report requires that the potential benefits of research justify the risks to participants?
- Respect for Persons
- Justice
- Beneficence (Correct answer)
- Autonomy
Correct answer: Beneficence
Beneficence requires researchers to maximize possible benefits and minimize possible harms, ensuring benefits justify risks.
Question 3: A sponsor-investigator discovers that a protocol deviation occurred due to a misunderstanding of the protocol. What is the FIRST required action?
- Terminate the participant from the study
- Notify FDA before any other action
- Document the deviation and notify the IRB promptly (Correct answer)
- Amend the informed consent form
Correct answer: Document the deviation and notify the IRB promptly
Protocol deviations must be promptly documented and reported to the IRB, which determines whether further regulatory reporting is necessary.
Question 4: ICH E6(R2) Good Clinical Practice guidelines require that the investigator ensure all study personnel have which of the following?
- Board certification in their specialty
- Adequate training for their assigned clinical trial tasks (Correct answer)
- At least 2 years of prior clinical trial experience
- IRB membership or observer status
Correct answer: Adequate training for their assigned clinical trial tasks
ICH E6(R2) requires investigators to ensure all study staff are qualified by education, training, and experience for their delegated tasks.
Question 5: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- Approving the study budget and resource allocation
- Monitoring accruing data to recommend early stopping if safety concerns emerge (Correct answer)
- Reviewing all informed consent forms prior to participant enrollment
- Auditing investigator compliance with GCP guidelines
Correct answer: Monitoring accruing data to recommend early stopping if safety concerns emerge
A DSMB independently monitors accumulating trial data and can recommend stopping or modifying a study based on safety, futility, or overwhelming efficacy.
Question 6: Under the Declaration of Helsinki, which statement BEST describes the ethical standard for placebo use in clinical trials?
- Placebos are never ethically permissible in any clinical trial
- Placebo controls are acceptable only when no proven intervention exists, or when compelling methodological reasons necessitate it and participants will not suffer serious harm (Correct answer)
- Placebos can be used whenever the sponsor deems them scientifically necessary
- The decision to use placebos rests solely with the IRB without any ethical constraints
Correct answer: Placebo controls are acceptable only when no proven intervention exists, or when compelling methodological reasons necessitate it and participants will not suffer serious harm
The Declaration of Helsinki allows placebos only when no proven intervention exists or when compelling methodological reasons require their use and participants won't suffer serious harm.
Question 7: Which regulatory document establishes the legal basis for an investigator's obligations when conducting an FDA-regulated clinical investigation?
- The study protocol signed by the sponsor
- FDA Form 1572, Statement of Investigator (Correct answer)
- The IRB approval letter
- The investigator's CV and credentials file
Correct answer: FDA Form 1572, Statement of Investigator
FDA Form 1572 is the legally binding agreement between the investigator and FDA, outlining the investigator's obligations under 21 CFR Part 312.
CPI Regulatory Compliance & Ethical Standards 2
Under 21 CFR Part 312, what is the maximum timeframe within which an investigator must report an unexpected serious adverse event to the IRB?