CTA Clinical Practices Guidelines 3 — Questions and Answers
Question 1: Which regulatory framework provides the foundational international standard for the design, conduct, and reporting of clinical trials?
- 21 CFR Part 11
- ICH E6(R2) Good Clinical Practice (Correct answer)
- HIPAA Privacy Rule
- ISO 14155
Correct answer: ICH E6(R2) Good Clinical Practice
ICH E6(R2) GCP is the internationally accepted standard for clinical trial conduct, accepted by regulatory authorities in the US, EU, and Japan.
Question 2: Under FDA regulations, an IND (Investigational New Drug) application must be submitted before which of the following?
- Finalizing the protocol
- Initiating clinical studies in humans in the United States (Correct answer)
- Publishing preclinical study results
- Obtaining IRB approval
Correct answer: Initiating clinical studies in humans in the United States
An IND must be in effect before a sponsor may ship an investigational drug across state lines or begin clinical studies in humans in the US.
Question 3: According to ICH E6, what must an investigator do if a subject experiences an adverse event that is both serious and unexpected?
- Treat the adverse event and document it in the medical records only
- Report it to the sponsor immediately and follow up with a written report (Correct answer)
- Wait until the end of the study to include it in the final report
- Notify only the IRB within 30 days
Correct answer: Report it to the sponsor immediately and follow up with a written report
Serious and unexpected adverse events must be reported to the sponsor immediately, who then assesses whether expedited regulatory reporting is required.
Question 4: What is the purpose of the Declaration of Helsinki in the context of clinical trials?
- To establish financial compensation standards for trial participants
- To provide ethical principles for medical research involving human subjects (Correct answer)
- To define statistical analysis requirements for clinical data
- To set manufacturing standards for investigational products
Correct answer: To provide ethical principles for medical research involving human subjects
The Declaration of Helsinki, adopted by the World Medical Association, provides foundational ethical principles governing medical research involving human subjects.
Question 5: A CTA notices that a site has been administering study drug to subjects after the protocol-specified window for dosing has closed. This is best classified as:
- A minor administrative error requiring no action
- A protocol deviation that must be documented and reported (Correct answer)
- An adverse event to be entered in the safety database
- A source data verification discrepancy only
Correct answer: A protocol deviation that must be documented and reported
Administering study drug outside the protocol-specified window is a protocol deviation that must be documented and reported to the sponsor and, if required, to the IRB.
Question 6: Which of the following best describes the role of a Data Safety Monitoring Board (DSMB)?
- To collect and enter case report form data on behalf of site staff
- To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination (Correct answer)
- To audit sponsor financial records for compliance
- To approve amendments to the study protocol
Correct answer: To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination
A DSMB (or Data Monitoring Committee) independently reviews unblinded safety and efficacy data at interim points to protect subject safety and trial integrity.
Question 7: Under 21 CFR Part 312, how long must an investigator retain clinical trial records after the investigation is discontinued or completed?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
Under 21 CFR 312.62, investigators must retain records for at least 2 years after the date on which a marketing application is approved, or 2 years after the investigation is discontinued.
CTA Clinical Practices Guidelines 3
Which regulatory framework provides the foundational international standard for the design, conduct, and reporting of clinical trials?