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The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC.The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial.
The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization. [1]The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search portal that allows access to the entire dataset.
The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The regulations repealed the previous legislation, namely the clinical trials directive and came into force on 31 January 2022. [1]
Clinical trial registration is the practice of documenting clinical trials before they are performed in a clinical trials registry so as to combat publication bias and selective reporting. [25] Registration of clinical trials is required in some countries and is increasingly being standardized. [ 26 ]
It is headquartered in Bonn, Germany. The core tasks of the BfArM as a regulatory authority include the approval and registration of medical devices and products, including drugs in the special therapeutic areas of herbalism and paraherbals, as well as the identification, assessment and defence against drug risks (pharmacovigilance).
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establishing guidelines for the manufacture, clinical trial, approval, distribution channels and monitoring of medicines and medical devices. The objectives are: quality, medical efficacy and safety; safety of biological medical products such as blood products; narcotics and addiction risk prevention; prevention, rehabilitation and disability ...