Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Site Management & Monitoring 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 Site Management & Monitoring flashcards as text

  1. During a routine monitoring visit, the CRA discovers that a site has enrolled a subject who did not meet an inclusion criterion. What is the FIRST action the CRA should take?

    Answer: Document the protocol deviation and notify the sponsor and IRB per protocol requirements

    Protocol deviations must be documented and reported to the sponsor and IRB according to the protocol's deviation management plan.

  2. Which document serves as the master reference for the rights and responsibilities of the sponsor, investigator, and institution at a clinical trial site?

    Answer: The Clinical Trial Agreement (CTA)

    The Clinical Trial Agreement outlines the legal obligations, responsibilities, and financial terms between the sponsor and the site/institution.

  3. A site coordinator calls to say the temperature in the investigational product storage refrigerator exceeded the acceptable range overnight. What should the CRA advise?

    Answer: Quarantine the affected product and notify the sponsor for disposition instructions

    Excursed investigational product must be quarantined and the sponsor's pharmacovigilance or supply team consulted before any use or disposal.

  4. In clinical trial monitoring, what does 'source data verification (SDV)' specifically confirm?

    Answer: That data entered in the CRF matches the original source records

    SDV ensures the accuracy and completeness of CRF data by comparing it directly against original source documents such as medical records.

  5. A monitoring visit report (MVR) should be completed and sent to the sponsor within which timeframe, per ICH E6 GCP guidance?

    Answer: A defined timeframe in the monitoring plan, typically within 5–10 business days

    ICH E6(R2) requires the CRA to document monitoring activities promptly; the specific timeframe is defined in the sponsor's monitoring plan, usually within 5–10 business days.

  6. When a site investigator is temporarily unavailable, which action is acceptable under GCP?

    Answer: A qualified sub-investigator listed on the FDA Form 1572 may perform delegated duties

    Only qualified individuals listed on the delegation log and, in the US, on FDA Form 1572 may perform investigator-delegated duties.

  7. Which of the following best describes a 'for-cause' monitoring visit?

    Answer: An unannounced visit triggered by a specific concern, data signal, or complaint

    For-cause visits are triggered by a specific issue such as data anomalies, safety signals, or regulatory concerns, unlike routine periodic visits.