SOCRA CCRP Practice Exam

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What FDA regulation governs the documents a sponsor should get from an investigator before trial initiation?

  1. 21 CFR 312.53(b)

  2. 21 CFR 312.53(c)

  3. 21 CFR 50

  4. 21 CFR 54

The correct answer is: 21 CFR 312.53(c)

Option A is incorrect because it pertains to the documents that the sponsor should get from the investigator after trial initiation, not before. Option C and D are incorrect because they refer to different regulations that are not specifically related to documents from investigators before trial initiation. The correct regulation is 21 CFR 312.53(b), which states that before a clinical trial begins, the sponsor must obtain a signed investigator statement and curriculum vitae from the principal investigator.

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