SOCRA CCRP Practice Exam

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What are the phases of device trials mentioned?

  1. Initial and Final

  2. Pilot and Pivotal

  3. Discovery and Verification

  4. Concept and Launch

The correct answer is: Pilot and Pivotal

The phases of device trials that are mentioned are pilot and pivotal. Pilot trials are conducted on a small group of people to assess the feasibility of the device and gather initial data on safety and effectiveness. Pivotal trials are larger and more rigorous, and are used to confirm the findings of the pilot trial and provide evidence of safety and effectiveness for regulatory approval. The other options are incorrect because they do not accurately reflect the specific phases mentioned in the question. Option A refers to "initial and final" which are very vague and could refer to any part of the trial process, not just specific phases. Option C includes "discovery and verification" which are not typically phases of device trials, and are instead used in the context of research and development. Option D includes "concept and launch" which also do not align with the phases mentioned in the question, as these are more related to the development and

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