Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 33

There is no doubt that the primary force in the regulatory environment is the regulatory or competent authority. They are provided under law with the necessary authority to affect control over most clinical trial activities including evaluating compliance with GCP through laws, regulations, directives, and other legal instruments. There is a layering of this authority in many countries and regions. For example in the USA there are Federal and State authorities which may have a role depending upon the nature of the research. In the European Union, it would be the Central Government Directorates and the health ministries for the member states. Supporting the authorities are AMCs which work to ensure that clinical trials are conducted in conformance with requirements and ethical standards through their infrastructure. Professional organizations complete the regulatory matrix.

The regulatory matrix may be more complete in some parts of the globe than others but as a concept it continues to expand providing protection to subjects in human clinical trials and further ensuring the quality of data supporting application decisions.