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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. According to ICH E6, which of the following is a key qualification requirement for a clinical trial investigator?

    Answer: Must be adequately trained and experienced to conduct the trial

    ICH E6 section 4.1 requires investigators to be qualified by education, training, and experience to assume responsibility for the trial.

  2. Under ICH GCP, an investigator who delegates trial tasks to study staff must ensure that:

    Answer: Each delegate is qualified and adequately trained for the assigned tasks

    ICH E6 section 4.2 requires investigators to ensure that any delegated individuals are qualified and trained for the specific tasks they perform.

  3. When a subject's condition requires a protocol deviation to avoid immediate harm, the investigator must:

    Answer: Document and explain the deviation and notify the sponsor and IEC promptly

    ICH E6 permits urgent deviations to protect subject safety but requires prompt documentation and notification to the sponsor and IEC.

  4. According to ICH E6, the investigator's brochure (IB) is provided to the investigator primarily to:

    Answer: Provide clinical and nonclinical data to support the safe use of the investigational product

    The IB compiles relevant clinical and nonclinical information to help investigators understand and manage risks associated with the investigational product.

  5. Which statement best describes an investigator's responsibility for investigational product accountability at the site?

    Answer: The investigator must maintain records of product receipt, use, return, and destruction

    ICH E6 section 4.6 requires the investigator to maintain accurate records of the investigational product at the site throughout the trial.

  6. Under ICH GCP, when is an investigator permitted to break the blind in a double-blind trial?

    Answer: Only when it is medically necessary to protect the subject's safety

    ICH E6 allows unblinding only when medically necessary for subject safety, and the investigator must document and promptly report the unblinding.

  7. An investigator fails to report a serious adverse event to the sponsor within the ICH GCP-required timeframe. This is considered a:

    Answer: Significant protocol deviation with potential regulatory and ethical consequences

    Failure to report SAEs within the required timelines is a significant GCP deviation that can compromise subject safety and data integrity, with regulatory consequences.