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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 CTRI requests all the information which the World Health Organization recommends for clinical trial registries. [8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs ...
The Clinical Establishments (Registration and Regulation) Act, 2010 is an Act of the Parliament of India.It seeks to regulate all clinical establishments in India. On April 15, 2010, the Clinical Establishments (Registration and Regulation) Bill, 2010 was introduced in the Lok Sabha for the first time.
Any company seeking approval to do clinical trials has to report the risks and benefits to patients for the research. [5] As a result of the ruling in 2014 India published new requirements for clinical trials. [6] The Supreme Court reprimanded an organization for not compensating victims who were injured. [7]
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare. [2] [3] In 2007, the organization established the Clinical Trials Registry - India, which is India's national registry for clinical trials. [4]
Clinical – efficacy and safety (clinical trials) Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements.
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]