Practice Test Geeks(SOCRA) Society of Clinical Research Associates Practice Test
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Essential Study Documents Flashcards

7 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. Under what circumstances is a protocol amendment required?

    Answer: Whenever there are changes to study objectives, design, endpoints, subject population, or procedures

    A formal protocol amendment is required for substantive changes to study objectives, design, statistical considerations, endpoints, subject population, or study procedures.

  2. What is the primary purpose of the Investigator's Brochure (IB)?

    Answer: To compile clinical and nonclinical data on the investigational product relevant to its study in humans

    The IB compiles clinical and nonclinical data about the investigational product to guide investigators in understanding the product's known and potential risks and benefits.

  3. How often must the Investigator's Brochure be reviewed and updated according to ICH E6?

    Answer: At least annually

    ICH E6 requires the IB to be reviewed at least annually, with updates issued whenever new significant information becomes available.

  4. A subject experiences a serious unexpected adverse drug reaction. How should this affect the informed consent document?

    Answer: The ICF must be updated and re-consented with enrolled subjects if the new risk is relevant to their participation

    When new safety information emerges that may affect a subject's willingness to continue, the ICF must be updated and subjects must be re-consented in accordance with GCP.

  5. What is the difference between a protocol deviation and a protocol violation?

    Answer: A deviation is any departure from the protocol; a violation is a departure that has a significant impact on subject safety or data integrity

    A protocol deviation is any departure from the protocol; when a deviation significantly impacts subject safety, rights, or data integrity, it is classified as a violation requiring expedited reporting.

  6. A subject requires emergency treatment that deviates from the study protocol to prevent immediate harm. What must happen?

    Answer: The deviation must be documented, and the sponsor and IRB must be notified as soon as possible

    Emergency protocol deviations must be documented and reported to the sponsor and IRB as soon as possible after the emergency, even though prior approval was not possible.

  7. IND safety reports (15-day expedited reports) submitted to the FDA must also be forwarded to:

    Answer: All participating investigators under the IND

    Under 21 CFR 312.32, sponsors must promptly distribute IND safety reports (SUSARs/expedited reports) to all investigators participating under the IND.