Practice Test Geeks(CCA) CATO Certified Associate Practice Test
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CATO Associate Ethics & Good Clinical Practice (GCP) Flashcards

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

Read the first 7 CATO Associate Ethics & Good Clinical Practice (GCP) flashcards as text

  1. Which ethical principle requires that the anticipated benefits of clinical research must justify the risks to participants?

    Answer: Beneficence

    Beneficence obligates researchers to maximize benefits and minimize harms so that the study's potential benefits justify the risks.

  2. A sponsor discovers a serious unexpected adverse drug reaction mid-trial. Under GCP, the expedited reporting window to regulatory authorities is typically:

    Answer: 7 calendar days for fatal/life-threatening events

    Fatal or life-threatening SUSARs must be reported to regulators within 7 calendar days; other SUSARs within 15 calendar days.

  3. An IRB/IEC must retain its records of approved studies for at least how long after study completion under ICH E6(R2)?

    Answer: As required by applicable regulations, but no less than 3 years

    ICH E6(R2) states that IRB/IEC records should be retained as required by applicable regulations, with a general minimum of 3 years post-completion.

  4. During site selection, a clinical monitor finds that the principal investigator has insufficient time to conduct the study. GCP requires the sponsor to:

    Answer: Not initiate the site

    GCP requires sponsors to select only sites where the investigator has adequate time and resources; a site should not be initiated if those conditions are not met.

  5. The Declaration of Helsinki's requirement for a 'post-study provision' means that:

    Answer: Participants should have access to beneficial interventions identified in the study

    The Declaration of Helsinki states that participants who benefited from study interventions should have access to them after the study ends.

  6. Which GCP document establishes the agreement between the sponsor and the investigator regarding study conduct, confidentiality, and publication rights?

    Answer: Clinical Trial Agreement (CTA)

    The Clinical Trial Agreement formalizes the responsibilities, financial terms, and rights between sponsor and investigator/institution.

  7. Under GCP, source documents are best defined as:

    Answer: Original records and certified copies from which CRF data are transcribed

    Source documents are the original records (e.g., hospital charts, lab reports) that provide the first-captured data for clinical trial entries.