Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 56

Standard setting organizations are generally seen as just that the “standard” setters. They have recognition as being thorough, authoritative, and quality oriented. The ICH is no exception and the ICH E6(R2) is hands down the final word when it comes to what constitutes good clinical practice. There are versions of the ICH E6(R2) good clinical practice guidelines published but for the most part they are renditions of the ICH E6(R2) which have been adapted to fit into the pharmaceutical regulatory scheme of a country, e.g. India. In addition organizations such as the World Health Organization (WHO) recognize the need for instructions such as that in ICH E6(R2) but are not standard setting entities themselves. The WHO has a handbook of GCP [1] but it is not advertised or promoted as a standard.