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Adverse Events Flashcards

6 cards from real SOCRA CCRP 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 a MedDRA in the context of adverse event reporting?

    Answer: Medical Dictionary for Regulatory Activities — a standardized medical terminology for AE coding

    MedDRA (Medical Dictionary for Regulatory Activities) is the internationally standardized medical terminology used to classify and code adverse events in clinical trials.

  2. What is the purpose of an Investigator's Brochure (IB) in adverse event management?

    Answer: To serve as the reference document for assessing the expectedness of adverse reactions

    The IB summarizes the clinical and nonclinical data on the investigational product and serves as the reference for determining whether an adverse reaction is expected.

  3. If an SAE is reported by an investigator to a sponsor, what is the sponsor required to do?

    Answer: Evaluate the SAE and report to regulatory authorities if it meets expedited reporting criteria

    Sponsors must evaluate SAE reports for seriousness, causality, and expectedness, and report to FDA and other regulatory authorities if expedited reporting criteria are met.

  4. What is the Common Terminology Criteria for Adverse Events (CTCAE) used for?

    Answer: Grading the severity of adverse events on a scale of 1 to 5

    CTCAE provides a standardized grading scale (Grade 1–5) for classifying the severity of adverse events, widely used in oncology trials.

  5. What is an 'expedited report' as opposed to a 'periodic report' for adverse events?

    Answer: Expedited reports are required within days for unexpected SAEs; periodic reports (e.g., annual reports) summarize all safety data

    Expedited reports (7 or 15 days) are required for unexpected serious adverse reactions, while periodic safety reports summarize all accumulated safety data on a scheduled basis.

  6. A participant in a clinical trial is hospitalized for a condition the investigator believes is related to the study drug. What should the investigator do first?

    Answer: Report the SAE to the sponsor immediately or per the protocol timeline

    Investigators must report SAEs to the sponsor immediately or within the timeframe specified in the protocol, regardless of whether the hospitalization has resolved.