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What does 21 CFR 56.115(b) relate to?

  1. Food safety regulations

  2. Electronic records and electronic signatures

  3. Clinical investigation practices

  4. Toxic substances control

The correct answer is: Clinical investigation practices

21 CFR 56.115(b) relates to clinical investigation practices under the Code of Federal Regulations Title 21, which governs food and drugs in the United States. Option A, food safety regulations, is incorrect as it falls under a different section of the CFR, specifically 21 CFR 117. Option B, electronic records and electronic signatures, is incorrect as it pertains to electronic submissions of clinical data, not the actual practices of conducting clinical investigations. Option D, toxic substances control, is also incorrect as it falls under a different section of the CFR, specifically 21 CFR 40.