CCA CATO Associate Ethics & Good Clinical Practice (GCP) 3 — Questions and Answers
Question 1: A participant in a Phase II oncology trial loses decision-making capacity mid-study. GCP guidance recommends:
- Continuing participation using previously collected consent
- Withdrawing the participant immediately regardless of benefit
- Obtaining consent from a legally authorized representative to continue (Correct answer)
- Obtaining a waiver of consent from the IRB
Correct answer: Obtaining consent from a legally authorized representative to continue
GCP requires that if a participant loses capacity, a legally authorized representative must provide consent for continued participation.
Question 2: The ICH E6(R2) addendum introduced which major new concept to strengthen GCP oversight?
- Mandatory electronic health records
- Risk-based quality management (QRM) (Correct answer)
- Centralized IRB review for all multi-site studies
- Mandatory biomarker collection
Correct answer: Risk-based quality management (QRM)
ICH E6(R2) introduced risk-based quality management, requiring sponsors to identify and mitigate critical risks to data quality and participant safety.
Question 3: Which of the following is a sponsor's responsibility under GCP regarding investigational product (IP) accountability?
- Dispensing IP directly to participants at home
- Maintaining systems to track IP receipt, use, return, and destruction at sites (Correct answer)
- Allowing investigators to purchase IP commercially if supplies run low
- Delegating all IP accountability to the IRB
Correct answer: Maintaining systems to track IP receipt, use, return, and destruction at sites
Sponsors must maintain drug accountability systems covering IP shipment, receipt, dispensing, return, and destruction at all trial sites.
Question 4: A CRO contracted by a sponsor defaults on its GCP obligations. Ultimate regulatory responsibility for trial quality remains with:
- The CRO
- The principal investigator
- The sponsor (Correct answer)
- The IRB/IEC
Correct answer: The sponsor
GCP stipulates that while a sponsor may transfer duties to a CRO, the sponsor retains ultimate regulatory responsibility for the trial.
Question 5: An investigator receives a protocol deviation report from a monitor. Under GCP, the investigator must:
- File the report and take no further action if minor
- Document the deviation, assess impact, and implement corrective actions (Correct answer)
- Immediately suspend the study pending IRB review
- Send the deviation directly to the FDA without sponsor notification
Correct answer: Document the deviation, assess impact, and implement corrective actions
GCP requires investigators to document all deviations, evaluate their impact on participant safety and data integrity, and implement CAPA as needed.
Question 6: In the context of GCP, 'blinding' or 'masking' is used primarily to:
- Protect the investigator's identity from the sponsor
- Reduce bias by preventing knowledge of treatment assignment (Correct answer)
- Conceal adverse events from regulatory agencies
- Anonymize participant data for publication
Correct answer: Reduce bias by preventing knowledge of treatment assignment
Blinding prevents knowledge of treatment assignment from influencing participant behavior or investigator assessments, thereby reducing bias.
Question 7: Which historical event most directly led to the development of the Nuremberg Code?
- The Tuskegee Syphilis Study
- Nazi medical experiments during World War II (Correct answer)
- The Thalidomide tragedy
- The Willowbrook hepatitis studies
Correct answer: Nazi medical experiments during World War II
The Nuremberg Code (1947) was drafted in response to Nazi physicians' unethical medical experiments on prisoners during World War II.
CCA CATO Associate Ethics & Good Clinical Practice (GCP) 3
A participant in a Phase II oncology trial loses decision-making capacity mid-study.
GCP guidance recommends: