Practice Test Geeks(CPI) Certified Physician Investigator Practice Test
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Emergency Procedures & Response Flashcards

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

Read the first 7 Emergency Procedures & Response flashcards as text

  1. A participant in a phase II trial reports chest pain. Which action reflects the correct order of priorities for a CPI?

    Answer: Provide immediate medical care, document the event, then notify the sponsor and IRB

    The correct order is: immediate medical care first, then thorough documentation and timely notification to sponsor and IRB.

  2. When a study is placed on clinical hold by the FDA due to safety concerns, investigators must:

    Answer: Immediately stop enrolling new subjects and follow FDA instructions regarding current participants

    An FDA clinical hold requires immediate cessation of enrollment and compliance with any FDA-directed actions for currently enrolled participants.

  3. Which element is NOT required in an investigator's SAE narrative report?

    Answer: Participant's financial status and insurance coverage

    SAE narratives require clinical details including timeline, medical history, concomitant medications, treatment, and outcome—financial or insurance details are irrelevant.

  4. The principal investigator is unreachable when a life-threatening SAE occurs at the clinical site. The sub-investigator should:

    Answer: Provide emergency care and notify the PI, sponsor, and IRB as required

    Sub-investigators are delegated authority to respond to medical emergencies; they must provide care and fulfill reporting obligations while notifying the PI as soon as possible.

  5. Emergency research conducted under 21 CFR 50.24 (exception from informed consent) requires which prospective community consultation step?

    Answer: Public disclosure and community consultation before initiating the research

    21 CFR 50.24 mandates prospective community consultation and public disclosure as prerequisites before conducting exception from informed consent research.

  6. A participant in a randomized controlled trial experiences an unexpected drug interaction requiring emergency hospitalization. The investigator should document this as:

    Answer: A serious adverse event (SAE) requiring expedited reporting

    Any hospitalization or prolongation of hospitalization that is unexpected meets the definition of a serious adverse event requiring expedited reporting.

  7. After emergency treatment alters a participant's study assessments (e.g., steroids given for anaphylaxis affect a biomarker endpoint), the investigator must:

    Answer: Document the emergency treatment and concomitant medications fully so data integrity is preserved

    All concomitant emergency treatments must be documented so data analysts can appropriately account for confounders while preserving data integrity.