SOCRA CCRP Practice Exam

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What is required in an IRB application regarding inc/exc criteria?

  1. A detailed plan for data analysis

  2. Documentation of IRB meetings

  3. Inclusion and exclusion criteria

  4. A list of potential side effects

The correct answer is: Inclusion and exclusion criteria

In an IRB application, inclusion and exclusion criteria are required to ensure that participants are selected fairly and fall within the specified parameters for the study. A detailed plan for data analysis (option A) is not required as part of the IRB application. Documentation of IRB meetings (option B) is important for internal records, but is not directly related to the inc/exc criteria. A list of potential side effects (option D) is not relevant to the IRB application, as it is focused on the ethical review and approval process, and not the specific details of the study.

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