Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 55

The ICH E6(R2) brings together the key functional areas of the drug development process that call for the application of the principles. If you wanted to study the requirements governing subject safety and data integrity from the FDA regulations you would need to organize the requirements from several different sections of the Code of Federal regulations. The ICH E6(R2) contains the information necessary to put in perspective the responsibilities of the sponsor, investigator, and IRB/EC all in one document. The applicable requirements of the respective regulatory authority are always referenced for details but the pathway for compliance with expectations that underpin subject safety and data integrity are available in one place.