CLINICAL TRIALS REGISTRY - INDIA, NATIONAL INSTITUTE OF MEDICAL STATISTICS, ICMR
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Attention Registrants: From 1st April 2018 CTRI will accept and register clinical trials/studies only prospectively i.e. before the enrollment of the first patient [future tentative Date of First Enrollment (India)] and Status is Not Yet Recruiting (India). Please follow up at ctri@gov.in for any pending unregistered trials.


Frequently Asked Questions


What is the Clinical Trials Registry - India?

 

What is the International Clinical Trials Registry Platform?

 

What is a Primary Register?

 

What is the ICMJE?

 

Why should I register my clinical trial?

 

Which clinical trials are required to be registered?

 

When should a clinical trial be registered?

 

Who is responsible for registering a clinical trial?

 

When is a trial considered to be registered?

 

What information is recorded in the CTRI?

 

What is the UTN?

 

My trial is already registered with another Primary Register, why do I need to register again with the CTRI?

 

When should studies be registered?

 

Is any payment required for registering clinical trials or accessing/viewing registered trials?

 

How can I register a trial with CTRI?

 

What is the trial registration process in the CTRI?

 

What happens once a trial is submitted to the CTRI?

 

What if a Registrant wishes to make changes in the trial data set after trial registration?

 



What is the Clinical Trials Registry - India?

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 (www.ctri.nic.in). 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 (http://www.who.int/ictrp/en/). 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.

 



What information is recorded in the CTRI?

 

The following information is recorded in the CTRI:


 

  • Public title of study

  • Scientific Title of Study (Give Trial Acronym, if any)

  • Secondary IDs, if any

  • Principal Investigator's Name and Address

  • Contact Person (Scientific Query)

  • Contact Person (Public Query)

  • Funding Source/s

  • Primary Sponsor

  • Secondary Sponsor

  • Countries of Recruitment

  • Site/s of study

  • Name of Ethics Committee and approval status

  • Regulatory Clearance obtained from DCGI

  • Health Condition/Problem studied

  • Intervention and Comparator agent

  • Key inclusion/Exclusion Criteria

  • Method of generating randomization sequence

  • Method of allocation concealment

  • Blinding and masking

  • Primary Outcome/s

  • Secondary Outcome/s

  • Status of Trial

  • Phase of Trial

  • Study Type

  • Date of first enrollment

  • Estimated duration of trial

  • Target sample size

  • Brief Summary

For detailed information and explanation of each field click on [ Trial Registration Set ]:

 



What is the UTN?

 

The Universal Trial Number (UTN) (earlier known as the UTRN) is a unique number which aims to facilitate the unambiguous identification of clinical trials registered in WHO Primary Registries and displayed on the WHO International Clinical Trials Registry Platform's (ICTRP) Search Portal. It is not a registration number. A UTN should be obtained early in the history of the trial and should:

 

  • Become permanently attached to the trial

  • be used whenever information about the trial is communicated

  • become part of the trial's identity

  • be documented in the trial protocol

  • be submitted every time the trial is registered


To obtain a UTN please go to http://apps.who.int/trialsearch/utn.aspx , and enter in your name, email and organization. WHO will then send you an email with a link to confirm your request. Once confirmed, you will receive a second email from WHO with your UTN details.


Please quote the obtained UTN number under SECONDARY ID. Currently obtaining the UTN is not mandatory.




My trial is already registered with another Primary Register, why do I need to register again with the CTRI?

 

A clinical trial being conducted in India, is also required to be registered in the CTRI as the CTRI captures data specific for the Indian arm of a trial, e.g. Site and PI details, Name of Ethics Committee and approval status, target sample size in India, start date in India etc. However, to Registrants must quote the Registration number of the other Primary Registry number in the Secondary ID section of the trial registration data set.



When should studies be registered?

 

Trials should be registered before enrolment of the first patient.

 



Is any payment required for registering clinical trials or accessing/viewing registered trials?

 

There is no charge for registering a trial. Registered trials are also freely accessible to the public.

 



How can I register a trial with CTRI?

 

To register their clinical trials, trialists must first register as users (obtain username and password). The username and password may be obtained by accessing the Home Page of the CTRI (www.ctri.nic.in) and filling the NEW USER form online and submitting it online. A confirmatory mail will be sent to the email ID provided and upon acceptance of this, an automated mail will be sent to inform the bona fide Registrant of the username and password.

 



What is the trial registration process in the CTRI?

 

Upon receiving username and password, the Registrant may login to the CTRI site and then click on TRIAL REGISTRATION and proceed to fill the Trial Registration Form. The form is available in several Parts. After filling Part 1, the data set form may be filled at the convenience of the Registrant. A trial may be submitted only after all the Parts of the data set are completed. Once the options "Approved/No Objection Certificate" (for EC approval status) or "Obtained/notified" status (for DCGI approval) is selected, the Registrant must upload the relevant documents to be able to SUBMIT the trial for further necessary action. Unless the SUBMIT button is clicked, the trial is not visible to the CTRI administrator.

 



What happens once a trial is submitted to the CTRI?

 

Once a trial is submitted to the CTRI, the CTRI scientists review the trial data set for meaningful and relevant entries. EC/DCGI approval documents are checked and verification mails sent to trial PIs and Contact persons. In case of any discrepancies or concerns, the trial may be sent back to the Registrant for appropriate modifications and/or clarifications. Upon satisfaction of the above criteria, the trial is registered and trial details viewable from the public domain. The uploaded EC/DCGI approval documents are not available in the public domain.

 



What if a Registrant wishes to make changes in the trial data set after trial registration?

 

A Registrant is expected to regularly update the trial status and other details of a registered trial (as applicable) in a timely manner. While the "Status of Trial" and sites with EC approval which are "Under Review" may be updated at any point of time after trial registration, other data set fields are "locked" upon registration. These fields may be "unlocked" after appropriate communication with CTRI scientists and then edited.

 





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