SOCRA CCRP Practice Exam

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Under which guideline section should investigators complete CRFs?

  1. FDA 21 CFR part 11

  2. ICH GCP guideline section 4.9

  3. EU Directive 2001/20/EC

  4. HIPAA Privacy Rule

The correct answer is: ICH GCP guideline section 4.9

According to ICH GCP guideline section 4.9, investigators should complete CRFs. Option A (FDA 21 CFR part 11) refers to electronic records and signatures, and does not specifically address CRFs. Option C (EU Directive 2001/20/EC) pertains to clinical trials in the European Union and does not mention CRFs. Option D (HIPAA Privacy Rule) applies to the privacy of personal health information in the United States, but does not specify CRFs. Therefore, option B is the most relevant and appropriate guideline section for completing CRFs.

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