Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 60

In this chapter you have learned that the ICH E6(R2) Guideline/Standard contributes more than just a list of must or should do expectations as a sponsor, investigator, or IRB plays out their role in the clinical trial endeavor. The Standard serves a policy document where needed; it is more than just the combination of its parts in that it lays out the best practices for functional expectations in terms of how to: design a trial; conduct a trial; record the details of a trial and how to report trial activities in a way that data integrity is maintained. The Standard also serves as a benchmark for ethical expectations for a trial thereby building into the process a moral obligation that would be missing from most standards. The ICH E6(R2) standard is not in and of itself a law but it comes as close to being that as any standard applicable to the clinical trial process. It is really a unique and one of a kind Standard.