Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 20

1 The emergence of legislative regulatory controls over pharmaceutical drug development and clinical trials was often prompted by:Protests from university medical students ______________Tragic outcomes from administration of unsafe and/or ineffective drug products_____________Promises made to voters by candidates for political office:______

2 Failure of medical researchers to apply ethical principles has never been a problem that needed solving? True ____ False ______

3 The Belmont Report was authorized by the National Research Act of 1974. True ____ False _______

4 The ICH Efficacy Guideline – GCP – is considered the industry standard for the conduct of human biomedical clinical trials with drug products. It was developed because:Of continuing abuses against study subjects by drug researchers _________The United States, Japan, and the European Union wanted manufacturers in their countries to have a monopoly on drug marketing _____________Manufactures and regulatory authorities wanted to establish harmonized standards to facilitate the mutual acceptance of clinical data supporting drug approval________

5 The ICH headquarters are located in the United States and the organization is under the US FDA. True __________ False ________