Clinical Trials - Guidelines and Databases
Guidelines - Clinical Trials
- Scientific guidelines - EMA (PK, clinical efficacy, safety, non clinical etc.)
- Scientific and compliance guidelines - FDA (efficacy, safety, biopharmaceutical, manufacturing, advertising etc.)
- ICH guidelines (efficacy, safety, quality, multidisciplinary)
Integrated databases of clinical trials
Company databases
Documents concerning disclosure of CT results
- Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases - here
- Joint Declaration of CPME and EFPIA on the Cooperation between the Medical Profession and the Pharmaceutical Industry, CPME-EFPIA June 2005 - here