CITI Training Practice Exam

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Which guideline requires consent forms to include a statement about granting access to the subject's original medical records for verification purposes?

  1. FDA

  2. ICH GCP

  3. EU Directive

  4. HIPAA

The correct answer is: ICH GCP

This guideline is known as the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guideline. Option A, FDA, is a regulatory institution in the United States, but it does not have specific guidelines for consent forms. Option C, EU Directive, refers to the European Union's regulations for clinical trials, but it also does not have specific requirements for consent forms. Option D, HIPAA, governs the privacy and security of personal medical information in the United States, but it is not specific to clinical trial consent forms. Therefore, the ICH GCP guideline is the most relevant and appropriate answer to this question.

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