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ICH-GCP Compliance Flashcards

7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 ICH-GCP Compliance flashcards as text

  1. Under ICH E6(R2), what is the sponsor's primary responsibility regarding a Contract Research Organization (CRO)?

    Answer: The sponsor retains ultimate responsibility for trial quality and compliance

    ICH E6(R2) states that the sponsor retains ultimate responsibility for the quality and integrity of the trial data even when duties are delegated to a CRO.

  2. Which ICH-GCP principle requires that each individual involved in conducting a trial be qualified by education, training, and experience?

    Answer: Principle of qualified personnel

    ICH E6(R2) Principle 2.8 specifies that each individual involved in conducting a trial must be qualified by education, training, and experience to perform their tasks.

  3. What does ICH-GCP require regarding the retention of essential documents after trial completion?

    Answer: Documents must be retained for the period required by applicable regulatory requirements

    ICH E6(R2) Section 4.9.5 requires that records be retained for the period specified by applicable regulatory requirements, which varies by jurisdiction.

  4. In ICH-GCP, which of the following best describes 'blinding' in the context of a clinical trial?

    Answer: A method where one or more parties are unaware of treatment assignment

    Blinding (masking) is a procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s) to reduce potential bias.

  5. According to ICH-GCP, when must a sponsor submit safety reports for unexpected serious adverse drug reactions?

    Answer: Within 7 calendar days for fatal/life-threatening events; 15 days for others

    ICH E6(R2) and ICH E2A require expedited reporting of unexpected SARs: 7 calendar days for fatal or life-threatening events and 15 calendar days for other unexpected serious ADRs.

  6. What is the role of the 'Data Safety Monitoring Board' (DSMB) as referenced in ICH-GCP guidelines?

    Answer: It is an independent group that reviews accumulating data to recommend trial continuation, modification, or termination

    A DSMB is an independent group that periodically reviews accumulating safety and efficacy data and advises the sponsor on whether to continue, modify, or stop the trial.

  7. Under ICH E6(R2), what must be done if a protocol deviation occurs at a clinical trial site?

    Answer: The investigator must document and explain the deviation; significant deviations must be reported to the sponsor and IRB/IEC

    ICH E6(R2) requires that investigators document protocol deviations and that significant deviations be reported to the sponsor, IRB/IEC, and regulatory authorities as applicable.