Question: 1 / 340

Under which guideline section should investigators complete CRFs?

FDA 21 CFR part 11

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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EU Directive 2001/20/EC

HIPAA Privacy Rule

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