SOCRA CCRP Practice Exam

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What FDA regulation allows investigators to withdraw a subject's participation at any time?

  1. 21 CFR 50.25(b)(2)

  2. 21 CFR 310.305

  3. 21 CFR 56.108

  4. 21 CFR 314.80

The correct answer is: 21 CFR 50.25(b)(2)

FDA regulation 21 CFR 50.25(b)(2) specifically states that investigators have the right to withdraw a subject's participation in a study at any time. This is an important regulation to ensure the safety and rights of participants. Choices B, C, and D do not pertain to this specific regulation and do not address the issue of withdrawing a subject's participation. Choice B deals with labeling requirements for over-the-counter drug products, choice C pertains to the review and approval of clinical investigations by an institutional review board, and choice D relates to the submission of marketing application and standards for drugs and biologics. These options do not address the specific concern of withdrawing a subject's participation, making them incorrect choices.

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