CTRI FAQ

What is the Clinical Trials Registry - India?
The Clinical Trials Registry - India (CTRI) launched on 20th July 2007 is managed by the ICMR-National Institute of Medical Statistics, New Delhi, India. The CTRI ( www.ctri.nic.in) is an online, free and searchable system for the prospective registration of all clinical studies being conducted in India. In addition, the CTRI also registers clinical studies being conducted in countries which do not have a Primary Registry of their own.

1.Are there any fees for registering a trial in the CTRI?
No, there areno fees for registering trials in the CTRI.

2. When should a clinical study be registered?
A clinical study should be registered prospectively i.e. before the enrolment of the first patient into the study.
 

3. Why should trials be registered in the CTRI?
Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.
 

4. Is it mandatory to register purely observational study?
The CTRI is a facilitator body that provides a platform for registering clinical studies as mandated by the drug licensing authority, ethics committees and journal editors. Further, the WHO advises 'When in doubt, register'.
In addition, it may be noted that since 1st April 2018, the CTRI only registers clinical trials prospectively, i.e., before the enrolment of the first patient and hence the decision to register should be made before trial initiation as registration will not be feasible later.
 

5. What documents, if any, are required to be submitted for study registration?
Submission/upload of ethics approval is mandatory for registration. In addition, submission of approval from the DCGI, wherever applicable, is also mandatory. In addition, email verification/confirmation of participation in trial by trial contact persons, i.e. overall trial PI, contact person Scientific query, Public query, Site PI (from the email ID provided in the CTRI form) is also mandatory.

6. How long does it take for a study to be registered?
Upon submission of a study to the CTRI, it is reviewed within 7 to 10 working days and sent back to registrant for clarifications/modifications. In addition, verification emails are sent to trial participants. Further action can only be taken by CTRI when the trial is resubmitted to the CTRI. Hence the time taken for trial registration is heavily dependent on the response of the registrant. The sooner the modifications are incorporated, approvals uploaded, verification received and trial resubmitted, the faster is the registration.
 

7. What is the process of registering a trial with CTRI?
To register clinical trials, Registrants 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 with username and password will be sent to the email ID provided. However this will be activated only upon receipt of a second confirmatory mail.Please login to CTRI and upload trial data by clicking on "ADD NEW TRIAL", and filling requisite data set form that appears. Please note that the form has to be filled online only and may be filled in parts at your convenience. For the trial to be available to CTRIfor review, please click on the Submit button that appears in the last section, i.e. Part 8 under the Brief Summary section to send the trial to CTRI for review.
 

8. What does it mean if both REF and CTRI number are indicated as 'Pending'?
If REF number is pending this indicates that the trial has not yet been submitted to the CTRI for processing.If CTRI number is pending this indicates that the trial has not yet been registered.
 

9. Now that one have an REF number can, begin enrolling patients in the trial?
No. Assignment of an REF number only indicates that the trial has been submitted to the CTRI for review. A trial is considered registered once it has been assigned a CTRI number. Further, since the CTRI only registers studies prospectively, if patient enrolment is initiated before it is registered (i.e. assigned a CTRI number) the trial will not be registered even if it has been assigned an REF number.

10. What is the procedure for deleting registered trial from the CTRI?
Once a trial is registered in the CTRI it cannot be deleted. However, if the trial is not conducted for some reason, the status of trial should be changed to Terminated and reason cited in the Brief Summary section. Suspended trials also need to follow the same procedure.
 

11. What type of clinical studies are registered in the CTRI?
All types of clinical studies, i.e. interventional, observational, bioavailability/bioequivalence and post-marketing studies are registered in the CTRI. In addition it may be noted that clinical studies from traditional medicinal systems as well as clinicalstudies conducted as part of post-graduate thesis are also registered in the CTRI.