CITI Training Practice Exam

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When does the concept of 'Sponsor-investigators' apply?

  1. Multinational pharmaceutical companies

  2. Government-funded research

  3. Investigator-initiated trials of investigational drugs

  4. Commercially-sponsored clinical trials

The correct answer is: Investigator-initiated trials of investigational drugs

The concept of 'Sponsor-investigators' applies specifically to investigator-initiated trials of investigational drugs. This means that the sponsor of the trial is also the investigator, which is not the case for options A, B, and D. Multinational pharmaceutical companies and commercially-sponsored clinical trials have separate sponsors and investigators, while government-funded research is sponsored by the government and may have a separate primary investigator. Therefore, 'Sponsor-investigators' only applies in the context of C, where the sponsor and investigator are one and the same.

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