Practice Test Geeks(SOCRA) Society of Clinical Research Associates Practice Test
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Basic Flashcards

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

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  1. What is the role of a Clinical Research Associate (CRA)?

    Answer: To monitor clinical trial sites and ensure protocol compliance

    A CRA (monitor) is responsible for monitoring clinical trial sites to ensure the study is conducted according to the protocol, GCP, and applicable regulations.

  2. What is a Case Report Form (CRF)?

    Answer: A document designed to record all required protocol data for each trial participant

    A Case Report Form (CRF) is a specialized document designed to collect all protocol-required data for each participant in a clinical trial.

  3. What is a Serious Adverse Event (SAE)?

    Answer: An adverse event resulting in death, hospitalization, disability, or is life-threatening

    A Serious Adverse Event is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, causes persistent disability, or is a congenital anomaly.

  4. What does blinding (masking) mean in a clinical trial?

    Answer: Keeping participants and/or investigators unaware of treatment assignments

    Blinding (masking) is a procedure where one or more parties in a trial are kept unaware of treatment assignments to prevent bias.

  5. What is the Declaration of Helsinki?

    Answer: A set of ethical principles for medical research involving human subjects

    The Declaration of Helsinki is a statement of ethical principles developed by the World Medical Association to guide medical research involving human subjects.

  6. What is the difference between efficacy and effectiveness in clinical research?

    Answer: Efficacy measures results under ideal conditions while effectiveness measures results in real-world conditions

    Efficacy refers to how well a treatment works under ideal, controlled conditions, while effectiveness refers to how well it works in routine, real-world clinical practice.