Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Clinical Practices 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 Clinical Practices Guidelines flashcards as text

  1. Which of the following is NOT typically considered a serious adverse event (SAE) under ICH E6 criteria?

    Answer: A mild headache resolving within 2 hours without intervention

    A mild, self-resolving headache does not meet the ICH E6 threshold for a serious adverse event, which requires death, life-threatening conditions, hospitalization, disability, or congenital anomaly.

  2. What is the primary goal of a clinical trial audit as distinguished from monitoring?

    Answer: To provide an independent, systematic evaluation of trial conduct and compliance separate from routine monitoring

    Auditing provides an independent quality assurance function that evaluates whether trial conduct, data collection, and analysis comply with the protocol, SOPs, and regulations, unlike routine monitoring.

  3. A site is using an electronic health record (EHR) to capture source data for a clinical trial. Under 21 CFR Part 11, the EHR system must:

    Answer: Meet requirements for electronic records and signatures, including audit trails and access controls

    21 CFR Part 11 requires electronic systems used in FDA-regulated trials to have audit trails, access controls, and validated processes ensuring data integrity.

  4. The concept of 'equipoise' in clinical trial ethics refers to:

    Answer: Genuine uncertainty within the clinical community about the comparative merits of the treatments being tested

    Clinical equipoise is the genuine uncertainty among expert clinicians about which intervention is superior, providing the ethical justification for randomizing subjects.

  5. An investigator site file (ISF) must contain which of the following documents before the first subject is enrolled?

    Answer: IRB/IEC approval letter and approved informed consent form

    IRB/IEC approval and the approved consent form must be in place and filed before any subject enrollment can begin, per GCP and regulatory requirements.

  6. When a sponsor issues a protocol amendment that changes the risk profile for enrolled subjects, what step is mandatory before subjects continue participation?

    Answer: Subjects must be re-consented using the updated informed consent form after IRB/IEC approval of the amendment

    Material changes to risk require IRB/IEC review and approval of an updated consent form, after which enrolled subjects must be re-consented before continuing.

  7. According to Good Clinical Practice, which of the following best describes the sponsor's responsibility regarding investigator selection?

    Answer: Ensuring selected investigators are qualified by training and experience and have adequate resources to conduct the trial

    ICH E6 requires sponsors to select qualified investigators with appropriate training, experience, and site resources necessary to conduct the trial properly and safely.