In order to cope up with the momentum in registration of clinical trials in the country which has been picking up fast ever since registration of clinical trials was made mandatory by the DCGI from June 15, 2009, the Union Health Ministry has upgraded the Clinical Trial Registry of India (CTRI) with several new features.
In the upgraded version, the CTRI has incorporated new features on audit trial, submission of EC-DCGI approval documents, trial transfer, trial search, etc.
In the new software application, once a trial is registered, all fields would be automatically 'locked' except for 'Recruitment status of trial'. In case changes are desired to be made, request has to be sent to the CTRI, quoting CTRI registration number, indicating the field that is to be changed. Accordingly, only the desired field will be 'unlocked' and once changes have been incorporated, the field will again become 'locked'. Further, all these changes will be available for public view, under 'Modifications' when a trial is viewed in the public domain. Uploaded documents if any are not visible in the public domain, although registrant may be able to view it upon login to CTRI.
For pre-registered trials, all fields remain unlocked except for those trials where Ethics Committee and DCGI approvals have been obtained. Registrants are encouraged to upload any additional information according to the new data. However, these changes will also be visible in the public domain under 'Modifications.'
In the upgraded version, the CTRI has incorporated new features on audit trial, submission of EC-DCGI approval documents, trial transfer, trial search, etc.
In the new software application, once a trial is registered, all fields would be automatically 'locked' except for 'Recruitment status of trial'. In case changes are desired to be made, request has to be sent to the CTRI, quoting CTRI registration number, indicating the field that is to be changed. Accordingly, only the desired field will be 'unlocked' and once changes have been incorporated, the field will again become 'locked'. Further, all these changes will be available for public view, under 'Modifications' when a trial is viewed in the public domain. Uploaded documents if any are not visible in the public domain, although registrant may be able to view it upon login to CTRI.
For pre-registered trials, all fields remain unlocked except for those trials where Ethics Committee and DCGI approvals have been obtained. Registrants are encouraged to upload any additional information according to the new data. However, these changes will also be visible in the public domain under 'Modifications.'
As per the upgraded version, EC-DCGI approval documents may now be uploaded from the CTRI site itself. The uploaded documents will not be visible in the public domain. It is now feasible to transfer a trial from one registrant to another, within a company or between companies. Besides, trials can be searched and viewed by using a single word search (keyword search) or specific field search (advanced search) or a layered search (trial search).
The Clinical Trial Registry of India was introduced by the government in July 2007 as part of its exercise to strictly regulate the clinical trial industry in the country. The National Institute of Medical Statistics (NIMS), an arm of the Indian Council for Medical Research (ICMR) was mandated with the responsibility of setting up and maintaining the CTRI.
Based on the experience of the pilot project, it was decided to implement a fresh well designed Web Hosted Clinical Trial Registry to meet the expectations of the various stakeholders including the pharmaceutical industry, researchers, publications, administrators and the public at large. Being a front runner, among the first 10 across the world, in the implementation of the mandate of registration of clinical trials, the Clinical Trial Registry of India is being keenly monitored across the world.
Source: Pharmabiz
Vidya Sury
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