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What must be included in a case history according to 21 CFR 312.62(b) and 812.140(3)?

  1. Records of dietary preferences

  2. Records of all observations pertinent to the investigation

  3. List of potential participants

  4. Email correspondence about the study

The correct answer is: Records of all observations pertinent to the investigation

A, C, and D are all incorrect choices because they are not mentioned in the regulations 21 CFR 312.62(b) and 812.140(3) as being required components of a case history. Option A, records of dietary preferences, may be helpful to have, but is not required by these specific regulations. Option C, a list of potential participants, is not mentioned as being part of the case history and may be covered in other parts of the application. Option D, email correspondence about the study, is not mentioned and may not be necessary for the case history. Option B, records of all observations pertinent to the investigation, is the correct answer because it is specifically listed as a requirement in the mentioned regulations.