Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Good Clinical Practice & ICH Guidelines Flashcards

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

Read the first 7 Good Clinical Practice & ICH Guidelines flashcards as text

  1. Under ICH E6(R2), which party is ultimately responsible for the overall conduct, integrity, and reporting of a clinical trial?

    Answer: The Sponsor

    The sponsor bears ultimate responsibility for the trial's overall conduct, integrity, and reporting, even when a CRO is delegated tasks.

  2. What is the minimum retention period for essential documents specified in ICH E6(R2) after study completion when no local regulation specifies otherwise?

    Answer: 2 years

    ICH E6(R2) specifies that essential documents must be retained for at least 2 years after the last marketing approval or after study discontinuation.

  3. Which ICH E6(R2) principle states that each individual involved in conducting a trial should be qualified by education, training, and experience?

    Answer: Principle 4

    ICH E6(R2) Principle 4 requires that each individual be qualified for their trial role by appropriate education, training, and experience.

  4. In GCP, what distinguishes a 'serious adverse event' (SAE) from an 'adverse event' (AE)?

    Answer: SAEs result in significant medical outcomes such as death or hospitalization; AEs may not

    An SAE meets at least one serious criterion (death, life-threatening, hospitalization, disability, congenital anomaly, or medically important event), whereas an AE is any untoward occurrence that may not meet these criteria.

  5. Under ICH E6(R2), a sponsor's audit of a clinical trial site is best described as:

    Answer: A systematic and independent examination of trial-related activities and documents by the sponsor

    An audit is a sponsor-conducted, independent examination to evaluate whether trial activities and data comply with the protocol, SOPs, GCP, and applicable regulations.

  6. Which section of the ICH E6(R2) guideline specifically addresses the content and maintenance of the Investigator's Site File (ISF)?

    Answer: Section 8 — Essential Documents

    Section 8 of ICH E6(R2) covers essential documents, cataloguing what must be maintained in both the investigator's and sponsor's trial master files.

  7. When a sponsor transfers trial-related duties to a CRO, ICH E6(R2) requires that:

    Answer: A written agreement clearly specifying transferred duties is established

    ICH E6(R2) requires a written agreement between the sponsor and CRO that defines which sponsor duties are delegated; the sponsor retains ultimate accountability.