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Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines [ 1 ] requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India .
The rule was that researchers must pre-register trials before the enrollment of any research participants. [5] In April 2018 the CTRI reiterated this rule, saying that there had been a practice of starting clinical trials and enrolling patients without registering the trial. [6] There had been past calls for preregistration. [7]
The council's research priorities coincide with National health priorities such as control and management of communicable diseases, fertility control, maternal and child health, control of nutritional disorders, developing alternative strategies for health care delivery, containment within safety limits of environmental and occupational health ...
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]
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
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.
AllTrials (sometimes called All Trials or AllTrials.net) is a project advocating that clinical research adopt the principles of open research.The project summarizes itself as "All trials registered, all results reported": that is, all clinical trials should be listed in a clinical trials registry, and their results should always be shared as open data.
A Phase IV trial is also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test. [1] Phase IV trials involve the safety surveillance ( pharmacovigilance ) and ongoing technical support of a drug after it receives regulatory approval to be ...