CITI Training Practice Exam

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If following ICH guidelines, who all should sign the consent form?

  1. Only the subject

  2. Subject and the person obtaining consent

  3. Witness and the person obtaining consent

  4. Subject, witness, and person obtaining consent

The correct answer is: Subject, witness, and person obtaining consent

When following ICH guidlines, it is important for both the subject and the investigator obtaining consent to sign the form. Additionally, a witness should also sign the form to verify that the subject gave their consent voluntarily and without any duress. Therefore, all three parties are required to sign the consent form according to ICH guidelines, making option D the correct answer. Option A is incorrect because it only includes the subject, neglecting the other two necessary parties. Option B is incorrect because it does not include the witness, who is responsible for verifying the subject's voluntary consent. Option C is incorrect because it does not include the subject, who is a key party in giving consent.

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