SOCRA CCRP Practice Exam

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What guidelines describe the essential documents for trial conduct?

  1. FDA Blue Book

  2. ICH GCP guideline, section 8

  3. ISO 14155

  4. E6(R2) Guideline for Good Clinical Practice

The correct answer is: ICH GCP guideline, section 8

The ICH GCP guideline, section 8, outlines the essential documents for trial conduct. While C and D may contain some information about trial conduct, they do not specifically outline the essential documents. Option A, FDA Blue Book, is not a recognized guideline for clinical trials and therefore would not provide accurate information about necessary documents.

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