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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 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 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 Clinical Trials Facilitation Group (CTFG) of the Heads of Medicines Agency issued a Q&A document in 2017 addressing Good Laboratory Practice (GLP) requirements within the context of clinical trials for human medicines. This document aims to provide clarification and guidance on GLP principles applicable to non-clinical safety studies ...
Open-ended research is conducted on the basis of applications for grants-in-aid received from scientists in non-ICMR Research Institutes, Medical colleges and Universities located in different parts of the country. Collaborative research projects with other institutes such as that between Institute of Pathology, Delhi and NCRM are also undertaken.
While most clinical trials test one alternative to the novel intervention, some expand to three or four and may include a placebo. [14] Except for small, single-location trials, the design and objectives are specified in a document called a clinical trial protocol. The protocol is the trial's "operating manual" and ensures all researchers ...
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A clinical trials registry is a platform which catalogs registered clinical trials. ClinicalTrials.gov, run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials, and remains the largest and most widely used. In addition to combating bias, clinical trial registries serve to increase ...