Clinical Trials Registry

The Clinical Trials Registry - India (CTRI) launched on 20^th 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.

What is a Primary Registry?

The WHO has set up a Registry Network wherein clinical trial registries with specific criteria for quality content validity accessibility etc. are designated as Primary Registries. There are currently 17 Primary Registries of the WHO, including the CTRI.Hence data of CTRI is also searchable from the WHO's International Clinical Trials Registry Platform (ICTRP). The ICTRP search portal ( http://apps.who.int/trialsearch/) provides a single point of access to trials registered across its network of registries. The US registry, i.e. ClinicalTrials.gov although the largest data provider to the ICTRP it is not a Primary Registry of the WHO.

I am a patient of bronchial asthma and would like to participate in a clinical trial exploring new treatment options. How can I search for such a trial?

Registered trials can be searched by using appropriate keywords (such as bronchial asthma) in the search box on the CTRI home page. Once the list of trials are displayed, the trial titles may be screened for shortlisting and details viewed for deciding possible feasibility of participating in a particular trial, given the status of trial (not yet recruiting or open to recruitment) as well as inclusion and exclusion criteria. For any help in this regard, an email may also be sent to ctri@gov.in.

Who is responsible for registering a 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 "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.

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.

My trial is already registered in another Primary Register, then 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.

But if the same trial is registered in two or more registries won't it be counted as separate trials?

To ensure that trials registered in multiple registries are publicly identified as a single trial, Registrants must quote the Registration number of the other Primary Registry number or Partner Registry number (ClinicalTrials.gov number) in the Secondary ID section of the CTRI trial registration data. This helps the trial to be identified as a single trial, despite being registered in two or more registries.

Is it mandatory to register my 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 1^stApril 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.

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.

The following information is recorded in the CTRI:

Public title of study

Scientific Title of Study (Trial Acronym, if any)

Secondary IDs

Principal Investigator's Name and Address

Contact Person (Scientific Query)

Contact Person (Public Query)

Sources of monetary or material support

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 enrolment

Estimated duration of trial

Target sample size

Brief Summary

Date of actual study completion

Final enrolment number achieved

For detailed information and explanation of each field click on [ Trial Registration Data Set] on the CTRI Home Page.

Is the trial registration dataset different for the different types of clinical studies?

Currently the trial registration data set is same for all types of clinical studies.

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.

Where do these documents have to be submitted?

As the CTRI is a paperless system, submissions are all online and these documents are to be uploaded into the system while filling the CTRI form. Verification is by email wherein trial designated Contact Person/s is/are expected to respond to the email sent by CTRI ( ctri@gov.in).

Are there any fees for registering a trial in the CTRI?

No, there areno fees for registering trials in the CTRI

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.

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.

I am doing a retrospective data collection study and I have begun the study. Can it still be registered?

No. Even retrospective data collection studies should be registered before the initiating data collection.

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.

I have submitted my trial over a month ago but there has been no response till now?

In such a situation please send an email to ctri@gov.in quoting your REF number.

Where can I locate my REF number?

Please login to your account in the CTRI and on your Welcome Page, the REF number would be mentioned alongside the trial title.

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.

How can I acquire an REF number for my trial?

To acquire an REF number, please fill all parts of the CTRI form and then click on the SUBMIT TRIAL TO CTRI button present under the Brief Summary section in Part 8. If all mandatory fields have been filled, the trial will be instantly be assigned an REF number will be displayed on your screen.

I clicked on the SUBMIT TRIAL TO CTRI button but the form failed to be submitted even though I filled all the field. What should I do?

In case of a tabulated list with cross marks please click on the link against which there is a cross mark and fill the relevant field such as Sources of Monetary and Material Support. Please note that this field is distinct from the Primary Sponsor field and should be filled by clicking on the ADD NEW button. In case of any other concerns please send a screenshot to ctri@gov.in

How can I find the health condition that is best suited for my study?

Please choose category of trial participant, healthy human volunteers or patients. Once Patients is selected, the ICD-10 coded drop down list provided up to a maximum of four levels of disease categories.. Sometimes the relevant disease category maybe available in the third or fourth category. For instance for dental trials, choose Diseases of digestive system (K series) and then Diseases of Oral cavity and salivary glands and at the third level the appropriate disease classification for your study. Similarly for Surgical/anaesthesia trials, the appropriate health condition would be available under (PCS) ICD 10 Procedure Coding System Codes. In case of any queries, please send an email to ctri@gov.in

Now that I have an REF number can I 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.

I uploaded my trial before enrolment of the first patient but started the trial as I was not aware about the REF and CTRI numbers. Can my trial be registered now?

No, the trial cannot be registered as only prospective registration is undertaken by the CTRI, i.e. registration before the enrolment of the first patient into the study.

From where can I obtain a certificate confirming the registration of my trial?

No certificate is issued upon registration of a trial. The CTRI number may be quoted wherever required as the registered trial would be viewable and searchable in the public domain ( www.ctri.nic.in). Further a PDF copy of the registered trial may be generated by clicking on the link above the trial details and submitting the same to the appropriate authority.

I can view my trial in the public domain at CTRI but not in the WHO search portal?

Upon trial registration trials are immediately viewable in the public domain from the CTRI. However, registered trial data are shared and uploaded at the ICTRP every month.

Even though my trial has been assigned a CTRI number, it is not searchable from Google?

Once a trial is registered with the CTRI, it may be viewed in the public domain by using relevant trial keywords (or the CTRI number) in the Keyword search box or advanced search options on the CTRI Home Page. Trials registered in the CTRI are also freely searchable from the WHO's search portal ICTRP or the International Clinical Trials Registry Platform ( http://apps.who.int/trialsearch/). While the CTRI database is searchable from other online search engines such as Google, however, this is not in the domain of CTRI.

What is the procedure for deleting my 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

Can I make changes in the trial details after it is registered?

To make changes in a registered trial, please follow the SOP detailed below:

For site addition/deletion- Please upload EC approval of additional site or site deletion under Ethics Approval - this field is permanently unlocked and revert by mail for site unlocking. Please also forward the list of new site/s and PI/s in the mail addressed to ctri@gov.inquoting the Reference Number in the subject line. For those sites which have not received EC approval, please mark a copy of the mail to the PI requesting a confirmation email to this email ID regarding their participation in trial.

For new contact person (Overall trial PI/Scientific/public query)- Please indicate new person, mark a copy of the mail to concerned person and request mail confirmation of responsibility quoting the Reference Number in the subject line.

For Interventional/Comparator agent/ inclusion & exclusion criteria, sample size, scientific title primary and secondary outcome, please specify changes (in a tabular format) mentioning the name of the section to be unlocked, previous information, present information and reason for change and confirm thatEC approval has been received for the amendments, if applicable, and upload in EC section which is permanently unlocked

What if I have some queries or concerns that are not addressed here?

In case of any other queries or concerns please send an email to ctri@gov.in quoting REF or CTRI number in the subject line, wherever applicable. You may also view the e-tutorial for CTRI available at http://ctri.icmr.org.in/

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