CITI Training Practice Exam

Does ICH require a witness when enrolling illiterate subjects?

1. True

2. False

3. Only in certain regions

4. Only if the FDA mandates

The correct answer is: True

ICH, or the International Conference on Harmonisation, sets guidelines for the conduct of clinical trials. According to ICH guidelines, it is required for a witness to be present during the enrollment of illiterate subjects to ensure that all necessary information is accurately conveyed and understood by the subject. Thus, options B, C, and D are incorrect because they suggest that a witness is not always required, when in reality, it is a mandatory requirement set by ICH.