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Protocol Deviations and Violations 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.

Read the first 7 Protocol Deviations and Violations flashcards as text

  1. Under ICH E6, when may an investigator implement a deviation from the protocol without prior sponsor agreement and IRB approval?

    Answer: When it is needed to eliminate an immediate hazard to trial subjects

    ICH E6 permits deviating without prior approval only when needed to eliminate an immediate hazard to subjects.

  2. After implementing an urgent deviation to protect a subject, what must the investigator do next per ICH E6?

    Answer: Submit the deviation, its reasons, and any proposed amendment to the IRB, sponsor, and regulators as required, as soon as possible

    ICH E6 4.5.4 requires prompt submission of the deviation, its reasons, and any proposed amendment to the IRB, sponsor, and regulatory authorities as required.

  3. A sponsor grants a prospective waiver allowing a site to enroll a subject who fails an inclusion criterion. How does FDA view this?

    Answer: It is a protocol change that needs IRB approval before it is implemented

    FDA treats prospective, intentional deviations such as eligibility waivers as protocol changes needing IRB review and approval before they are implemented.

  4. A subject's Week 8 visit happens 2 days outside the protocol window, with no impact on safety or key endpoints. How is this usually handled?

    Answer: Documented as a minor deviation and reported per sponsor and IRB policy

    Window deviations with no safety or data-integrity impact are usually minor and are documented and reported according to sponsor and IRB requirements.

  5. A monitor finds dosing errors happening repeatedly at one site. What is the most appropriate response?

    Answer: Perform root cause analysis and carry out a CAPA plan such as retraining and process changes

    Recurring deviations call for root cause analysis and corrective and preventive action to stop them from happening again.

  6. A monitor finds that a subject's screening blood draw happened before the informed consent form was signed. How should this be classified?

    Answer: An important or major deviation affecting subject rights that must be reported per IRB policy

    Doing study procedures before informed consent violates subject rights under 21 CFR 50 and is an important deviation.

  7. Under 21 CFR 312.56(b), what must a sponsor do when an investigator is not complying with the protocol?

    Answer: Promptly secure compliance, or stop the investigator's participation and notify FDA

    21 CFR 312.56(b) requires the sponsor to secure compliance promptly, or to end the investigator's participation, recover the drug, and notify FDA.