EU Clinical Trials Registry
The World Health Organization (WHO) has recognized the EU Clinical Trials Register (CTR) as the primary registry for the International Clinical Trials Registry Platform (ICTRP), a web-based portal that contains information from a number of clinical trials registries from around the world.
EU-CTR: Clinical Trials Information in the EEAWiththe EU-CTR, researchers can complete the necessary registration in a public registry simultaneously with the approval of the clinical trial application. In the EU-CTR, data on clinical drug trials from the European Economic Area (EEA) are available, as well as information on those trials that are conducted outside the EEA but are part of a paediatric investigation plan (PIP).The EU-CTR, a database of the European Medicines Agency (EMA), has been publicly accessible since March 22, 2011.
The Good Clinical Practice (GCP) guidelines and the International Committee of Medical Journal Editors (ICMJE) require that a clinical trial be reported in a publicly accessible registry before an article can be accepted.
With the agreement and support of national authorities, concerted efforts have been made for years toward WHO recognition of the EU CTR.
Further information:
Further inquiries:
AGES PharmMed
Institute Regulatory Affairs & Lifecycle Management
E-mail: c linicaltrials@ages.at
