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ICH Good Clinical Practice Flashcards

7 cards from real SOCRA 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 Good Clinical Practice flashcards as text

  1. Under ICH E6, what is the sponsor's primary obligation regarding the selection of clinical investigators?

    Answer: Ensure investigators are qualified and have adequate resources to conduct the trial

    ICH E6 section 5.6 requires sponsors to select investigators who are qualified and have sufficient resources—staff, facilities, time—to conduct the trial properly.

  2. According to ICH GCP, a sponsor who transfers trial-related duties to a CRO must ensure that:

    Answer: All transferred obligations are specified in writing and the sponsor retains ultimate responsibility

    ICH E6 section 5.2 states that CRO responsibilities must be documented in writing, but the sponsor retains ultimate responsibility for trial quality and compliance.

  3. The purpose of a clinical trial monitor according to ICH E6 is to:

    Answer: Verify that trial conduct, data, and records comply with protocol, GCP, and regulations

    ICH E6 section 5.18 defines monitoring as an oversight activity to verify data accuracy and that the trial is conducted in accordance with the protocol, GCP, and applicable regulations.

  4. Under ICH GCP, the extent and nature of monitoring should be determined primarily by:

    Answer: Consideration of the trial's objective, design, complexity, size, and endpoints

    ICH E6 section 5.18.3 requires a monitoring plan based on trial-specific factors such as design, complexity, blinding, and primary endpoints.

  5. Which of the following is an example of an expedited safety report the sponsor must submit to regulatory authorities?

    Answer: An unexpected serious adverse reaction that is possibly related to the investigational product

    SUSARs—Suspected Unexpected Serious Adverse Reactions—must be expeditiously reported to regulatory authorities and investigators per ICH E6 and E2A.

  6. Under ICH GCP, the sponsor must ensure that the clinical trial protocol includes:

    Answer: Statistical methods, including timing of interim analyses and stopping rules

    ICH E6 section 6 requires the protocol to include a description of statistical methods, including planned interim analyses and predefined stopping criteria.

  7. According to ICH GCP, a sponsor must retain essential trial documents for:

    Answer: A period that satisfies applicable regulatory requirements, typically 2 years post-last-approval or longer

    ICH E6 section 5.5 requires document retention to satisfy regulatory requirements, typically at least 2 years after the last marketing approval or longer per local law.