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Friday, February 4, 2011

CTRI

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Registration of Observational Trials
Currently, observational trials are NOT being registered in the CTRI. However, if submitted, such trials are being registered.
Trial registration made mandatory by DCGI
As per DCGI decision, trial registration, before the enrollment of the first patient has become mandatory for all trials initiated after 15th June 2009
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Site Last Updated on
June 24, 2010.
The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office. [Read more...]

Clinical Trials Registry-India (CTRI)


The CTRI is an online register of clinical trials being conducted in India. Any researcher who plans to conduct a trial involving human participants, of any intervention (drug, surgical procedure, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies and complementary therapies) are expected to register the trial in CTRI before enrollment of the first participant. Registration is voluntary but some fields marked* are mandatory for registration to proceed. Some fields marked WHO also need to be filled if the trial is to receive a registration number and fulfill WHO/ICMJE requirements. Incomplete entries will be given a provisional registration number that will not suffice for purposes of publication in journals that endorse the ICMJE recommendations for trial registration. Registration of trials in the CTRI is free. All registered trials will be made publicly available. The CTRI will be searchable by anyone free of charge. The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office. [Read more...]
Mission

The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. [Read more...]
Vision

The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the 20-item WHO ICTRP dataset, as well all items of the CTRI dataset, in order to 1) improve transparency and accountability, 2) improve the internal validity (details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results) of trials right from the design,through conduct and reporting, 3) conform to accepted ethical standards and 4) lead to reporting of all relevant results of all clinical trials in India and the region. [Read more...]


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