SOCRA CCRP Practice Exam

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What is required to be documented in case histories per 21 CFR 312?

  1. Informed consent obtained prior to participation

  2. Participants' genetic information

  3. Participants' income level

  4. Future research plans

The correct answer is: Informed consent obtained prior to participation

Case histories per 21 CFR 312 require documented proof of informed consent being obtained from participants prior to their participation in the study. This is a crucial aspect of ethical research and ensures that participants are fully aware and agree to the potential risks and benefits of the study. While obtaining informed consent is important, it is not necessary to document participants' genetic information or income level for case histories. Additionally, future research plans are not relevant to the documentation of case histories per 21 CFR 312.

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