Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 52

The thirteen principles of ICH E6(R2) set a cultural tone which brings together ethical considerations, scientific requirements, and regulatory details in a succinct set of statements that are not always found in codes or regulations. In the United States, the FDA would have described such aspects in a preamble to a set of proposed regulations but would not have memorialized such principles in the regulations that are promulgated. However, having a set of principles to draw on gives the clinical trial players a set of cultural and ethical building blocks to use as they develop an investigational plan, prepare a protocol and train staff to conduct a clinical trial.

The high‐level statements of principle that are found in this section of the ICH E6(R2) provide a reference point for just about every requirement that can be found in the lengthy and detailed requirements of the regulatory authorities. One could easily substitute the term policy for principles. The thirteen principles are the policies that will govern the entire scheme of a clinical trial activity from the time an application is submitted to a regulatory authority to the time the last subject is enrolled. See Chapter 6.