CITI Training Practice Exam

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Regarding the requirement for dates on subject signature on consent forms, this is required by:

FDA only
ICH only
Both FDA and ICH
Neither FDA nor ICH

The correct answer is: Both FDA and ICH

Both FDA and ICH require dates on subject signature on consent forms. Although FDA does not explicitly state this requirement in their regulations, it is implied based on the need for accurate documentation to ensure compliance with FDA regulations. Similarly, ICH guidelines also emphasize the importance of accurate and complete documentation, including the date of subject signature on consent forms. Therefore, both FDA and ICH require dates on subject signature on consent forms. Option A is incorrect because FDA does not solely require this, and option B is incorrect because ICH does not solely require this. Option D is incorrect because both FDA and ICH require this.