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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. Which ICH-GCP section specifically addresses the investigator's responsibilities for investigational product accountability?

    Answer: ICH E6(R2) Section 4.6

    Section 4.6 of ICH E6(R2) outlines the investigator's responsibilities for accountability of the investigational product, including maintenance of accurate records.

  2. What is the significance of the 'Declaration of Helsinki' in relation to ICH-GCP guidelines?

    Answer: ICH-GCP was developed with consideration of the ethical principles in the Declaration of Helsinki

    ICH E6(R2) states that the guideline was developed with consideration of current good clinical practices of the EU, Japan, the US, and the ethical principles of the Declaration of Helsinki.

  3. Under ICH-GCP, which of the following constitutes an 'essential document'?

    Answer: Documents that individually and collectively permit evaluation of the conduct of a trial and quality of data

    ICH E6(R2) Section 8 defines essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.

  4. When an IRB/IEC reviews a clinical trial, what is the primary ethical concern ICH-GCP requires them to address?

    Answer: Safeguarding the rights, safety, and well-being of all trial subjects

    ICH E6(R2) states that the IRB/IEC's primary purpose is to safeguard the rights, safety, and well-being of all trial subjects.

  5. In a multi-center trial conducted under ICH-GCP, who is responsible for coordinating safety information across all sites?

    Answer: The sponsor

    The sponsor is responsible for the ongoing safety evaluation of the investigational product and for coordinating and reporting safety information across all participating sites.

  6. Under ICH E6(R2), what is required before a subject can be enrolled in a clinical trial?

    Answer: Written informed consent must be obtained from the subject or legally acceptable representative

    ICH E6(R2) Section 4.8 requires that freely given, written informed consent be obtained from each subject prior to trial participation.

  7. What does ICH-GCP specify regarding the qualification of a clinical trial monitor?

    Answer: Monitors should be trained in scientific and/or clinical disciplines and knowledgeable about GCP and regulatory requirements

    ICH E6(R2) Section 5.18.2 states that monitors should have scientific and/or clinical knowledge sufficient to monitor the trial adequately and should be knowledgeable about GCP and applicable regulatory requirements.