CATO Associate Ethics & Good Clinical Practice (GCP) Flashcards
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Read the first 7 CATO Associate Ethics & Good Clinical Practice (GCP) flashcards as text
A participant in a Phase II oncology trial loses decision-making capacity mid-study. GCP guidance recommends:
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.
The ICH E6(R2) addendum introduced which major new concept to strengthen GCP oversight?
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.
Which of the following is a sponsor's responsibility under GCP regarding investigational product (IP) accountability?
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.
A CRO contracted by a sponsor defaults on its GCP obligations. Ultimate regulatory responsibility for trial quality remains with:
Answer: The sponsor
GCP stipulates that while a sponsor may transfer duties to a CRO, the sponsor retains ultimate regulatory responsibility for the trial.
An investigator receives a protocol deviation report from a monitor. Under GCP, the investigator must:
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.
In the context of GCP, 'blinding' or 'masking' is used primarily to:
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.
Which historical event most directly led to the development of the Nuremberg Code?
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.