[The community clinical trial system EudraCT at the EMEA for the monitoring of clinical trials in Europe].
The GCP-Directive 2001/20/EG has been implemented in Germany by the 12th Amendment to the Drug Law of 6 August 2004 and the GCP-Ordinance of 9 August 2004, introducing new regulations for performing clinical trials. The information and documentation requested by the GCP-Ordinance to apply for the approval of a clinical trial can be partially prepared by using the EudraCT database. Crucial administrative and scientific information on a clinical trial is presented by the applicant to the EU member states in a harmonized manner. After the implementation of the data into the Community Clinical Trial Database System for member states, the clinical trials performed in some member states become comprehensible for the whole of the community. This increased transparency of planned, ongoing or finalized clinical trials will be an advantage for the safety of the participants.
Krafft
H
H
Ehrlich-Institut, Langen. Kraha@pei.de
D000047:Academies and Institutes / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005544:Forecasting; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006301:Health Services Needs and Demand; D006801:Humans; D007880:Legislation, Drug; D011786:Quality Control; D012109:Research Support as Topic / Q000331:legislation & jurisprudence