SOCRA CCRP Practice Exam

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What is required alongside patient or LAR consent according to 21 CFR 50?

  1. Verbal agreement

  2. Documentation of informed consent

  3. A witness present

  4. Payment information

The correct answer is: Documentation of informed consent

To ensure ethical practices in patient care and research, the United States Code of Federal Regulations (21 CFR 50) requires documentation of informed consent to be obtained from either the patient or their legally authorized representative (LAR). This documentation serves as evidence that the patient or LAR has been fully informed about the nature and risks of the treatment or research being conducted. Options A and C are incorrect because they do not fulfill this requirement of documentation. Option D, payment information, is irrelevant as it is not relevant to obtaining informed consent.

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