CITI Training Practice Exam

What does the ICH E6 guideline for good clinical practice provide?

1. A unified standard for archival of clinical trial documents

2. A unified standard for clinical trial design, conduct, recording, and reporting

3. Guidelines for pharmaceutical marketing

4. Guidelines for patient recruitment in clinical trials

The correct answer is: A unified standard for clinical trial design, conduct, recording, and reporting

The ICH E6 guideline for good clinical practice provides a unified standard for clinical trial design, conduct, recording, and reporting. This includes guidelines for study design, data collection and management, as well as the ethical considerations and principles to be followed throughout the entire clinical trial process. Option A is incorrect because the guideline covers much more than just archival of documents. Option C is incorrect because the ICH E6 guideline is focused on the conduct of clinical trials, not pharmaceutical marketing. Option D is incorrect because while the guideline does address patient recruitment, it covers a much broader scope of topics related to clinical trials.