Status Check, Procedures, Facilities

Organisation : Clinical Trials Registry- India (CTRI)
Facility : Registration

Registration Form here : http://ctri.nic.in/Clinicaltrials/app_register.php
http://nims-icmr.nic.in/NIMS/index.jsp
Website : http://ctri.nic.in/

Registration :

The Clinical Trials Registry – India (CTRI), set up at the National Institute of Medical Statistics, ICMR, New Delhi is a free and online system for registration all clinical trials being conducted in India.

Related : AMFI Registration / Renewal : www.statusin.in/20117.html

Registration of clinical trials in the CTRI is now mandatory, as per notification of the Drugs Controller General (India). Trials registered in the CTRI are freely searchable, both from the CTRI site as well as the International Clinical Trials Registry Platform (ICTRP).

What is the International Clinical Trials Registry Platform?
The ICTRP is a network of Primary Registers, which has been developed by the WHO. The mission of the WHO’s ICTRP is to ensure that a complete view of research is accessible to all those involved in health care decision making.

The ICTRP in itself is not a Registry, but collects data (details of registered trials) from its Primary Registers and displays them from a single search portal. Thus the ICTRP serves as a one-stop search portal for clinical trials that may be registered in diverse Primary Registers of the world.

What is a Primary Register?
A Primary Registry in the WHO Registry Network is a clinical trial registry with at least a national remit that meets WHO Registry Criteria for content, quality and validity, accessibility, unique identification, technical capacity and governance and administration.

Primary Registries have the support of the ICMJE. There are currently 11 Primary Registries in the WHO Registry Network, including the CTRI.

What is the ICMJE?
The International Committee for Medical Journals Editors (ICMJE) released an editorial statement on compulsory registration of clinical trials in 2004.

According to this statement, the ICJME proposed comprehensive trial registration as a solution to the problem of selective awareness and announced that all eleven ICJME member journals would adopt a trials-registration policy to promote this goal [N. Engl. Med. J. 2004 351; 1250-1251.]

The ICJME member journals now require, as a consideration for publication, registration in a public trials registration. Trials must register at or before the onset of patient enrollment.

This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, the ICJME member journals were required registration by September 13, 2005, before considering the trial for publication.

Why should I register my clinical trial?
In its latest General Assembly held on 18th October 2008, the World Medical Association, in its revision of the Declaration of Helsinki among other modifications, specifies that “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”

Further, as mentioned above, ICMJE member journals require submission of the trial registration number prior to consideration of clinical trial data for publication. In addition, Editors of Biomedical Journals of 11 major journals of India, in February 2008, also called for trial registration in a publicly accessible database [Indian J. Med. Res. 2008; 126: 104-105].

Importantly, The Drugs Controller General (India) has made trial registration in the CTRI mandatory with effect from 15th June 2009.

Which clinical trials are required to be registered?
Studies that meet the WHO/ ICMJE 2008 definition of a clinical trial should be registered. That is, any research study that prospectively assigns human participants or groups of humans to one or more health related intervention to evaluate the effects on health outcomes.

Health related interventions include any intervention used to modify a health outcome and include drugs, surgical procedures, devices, behavioral treatments, etc.

Thus, all interventional clinical trials, involving drugs, devices, biologicals, vaccines, herbal compounds etc are required to be registered. In addition, observational trials, bioavailability and bioequivalence trials as well as post marketing surveillance trials may also be registered in the CTRI.

For researchers in doubt whether or not to register their trials, both the WHO and ICMJE urges researchers to go ahead and register the trial.

When should a clinical trial be registered?
The global mandate is to register all clinical trials prospectively, i.e. before the enrollment of the first patient. Currently, ongoing and completed trials are also being registered, although at a later date, only prospective trials may be registered. Hence, it is advisable for all clinical trials, to be registered at the earliest.

Who is responsible for registering a clinical trial?
A Responsible Registrant, Trialist or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility.

The “Responsible Registrant” for a trial is either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between the parties.

The primary sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center and multi-sponsor trials, it is the lead PI or lead sponsor who should take responsibility for registration.

When is a trial considered to be registered?
A trial is considered to be registered when an internationally agreed set of information about the design, conduct and administration of clinical trials is publicly available in a Primary Registry, before the enrollment of the first patient.