Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 51

The objectives of this chapter are to:

 Demonstrate how the ICH E6(R2) Guideline serves to underpin those practices which support subject safety and data integrity within the context of meeting regulatory authority requirements.

 Outline several ways the ICH guideline elements moved the conduct of clinical trials closer to meeting the expectation of regulatory compliance and best practices.

Since this text is devoted to explaining fundamental precepts for good clinical practice this chapter will not address each topic area but rather select several examples of how the ICH E6(R2) moves clinical research several steps higher than the regulatory expectations which are generally acknowledged to be the minimum requirements for compliance with a statute, directive, or code.