Certified Clinical Research Associate (CCRA) Practice Exam

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Prepare for the CCRA Exam with interactive flashcards and multiple choice questions, each offering hints and detailed explanations. Equip yourself with the knowledge you need for certification success!

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What is required from the IRB after using an investigational product without informed consent?

  1. The patient must be informed within 30 days

  2. The IRB must be notified within five working days

  3. Consent must be obtained afterwards

  4. Additional testing must be conducted

The correct answer is: The IRB must be notified within five working days

The correct answer emphasizes the requirement for timely communication with the Institutional Review Board (IRB) following the use of an investigational product without informed consent. When such a situation occurs, regulatory guidelines mandate that the IRB must be notified within five working days to ensure proper oversight and evaluation of the circumstances surrounding the incident. This notification helps the IRB assess any risks to the patient and determine whether further action is needed to protect participant welfare and maintain ethical standards in research. While informing the patient within 30 days or obtaining consent afterwards may be important aspects of clinical research practices, the direct requirement for notifying the IRB within a specified timeframe is a crucial regulatory step to ensure that an ethical review is conducted promptly. Additional testing might be necessary in some cases, but it is not specifically mandated in the scenario described regarding the lack of informed consent.