Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 61

1 The 13 principles found in the ICH E6(R2) were copied from the US FDA’s regulations governing the conduct of investigation new drug studies found at 21 CFR 312. True ___ False ____

2 Would the maintenance of subject medical history and records confidentiality be categorized as a record keeping function or a trial conduct function? ____________

3 Review the ICH E6(R2) Standard and prepare a list of 15 sections where the term procedures is listed. Can you find the same requirement/expectation in the regulations from a regulatory authority?

4 The author states that the ICH is a respected organization. Briefly describe several reasons why you believe the ICH is respected and its Standards seen as authoritative

5 The ICH E6(R2) Guideline calls for the clinical trial investigator to ensure that informed consent is given to each subject. Do you think that requirement was universal when the Standard was issued circa 1996? Do you know which benchmark ethical publication/policy document first called for informed consent of human subjects?