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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

  1. A participant enrolled in a double-blind RCT requests to know which treatment arm they are in. GCP guidance is that:

    Answer: Unblinding should occur only if medically necessary, following the emergency unblinding procedure

    Emergency unblinding is permitted only when knowledge of treatment assignment is necessary for the participant's immediate medical care, using the pre-defined unblinding procedure.

  2. The Belmont Report's principle of 'justice' in research ethics is most concerned with:

    Answer: Fair distribution of research burdens and benefits across populations

    Justice requires that the selection of research subjects be equitable so that no group bears a disproportionate burden or is excluded from benefits.

  3. A site co-investigator leaves the institution mid-trial. Under GCP, the principal investigator must:

    Answer: Notify the sponsor and update the delegation log, reassigning the co-investigator's tasks

    Personnel changes must be documented on the delegation log and communicated to the sponsor so oversight and task coverage are maintained.

  4. Which document provides investigators with comprehensive clinical and non-clinical information about the investigational product to support safe trial conduct?

    Answer: Investigator Brochure (IB)

    The Investigator Brochure compiles all available clinical and preclinical data on the IP to help investigators understand risks and benefits.

  5. Under GCP, the minimum age for an individual to provide independent informed consent without a guardian in the US is governed by:

    Answer: State law, which typically sets the age of majority at 18

    In the US, the age for independent consent is determined by state law (generally 18), and federal regulations defer to applicable state law for the age of majority.

  6. A sponsor is conducting a decentralized clinical trial (DCT) with remote visits. GCP requires that source data captured remotely must be:

    Answer: Attributable, legible, contemporaneous, original, and accurate (ALCOA)

    Regardless of the trial modality, all source data must meet ALCOA principles to ensure data integrity and traceability.

  7. An investigator proposes adding a questionnaire to collect additional patient-reported outcomes not in the original protocol. GCP requires:

    Answer: A formal protocol amendment approved by both the sponsor and IRB/IEC before implementation

    Any change to the protocol, including addition of assessments, requires a formal amendment reviewed and approved by the sponsor and IRB/IEC before implementation.