CITI Training Practice Exam

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What term is used for clinical trials of drugs or devices where the data will be submitted to support a marketing application to the FDA?

  1. Covered clinical studies

  2. Open clinical trials

  3. Blind clinical studies

  4. Controlled experiments

The correct answer is: Covered clinical studies

A. Covered clinical studies are the only type of clinical trials that involve submitting data to the FDA for a marketing application. Open clinical trials are when both the researchers and participants know which treatment is being given. Blind clinical studies are when either the researchers or participants are unaware of the treatment being given. Controlled experiments are a type of research design, but not specifically used for clinical trials of drugs or devices.

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