What is the Clinical Trials Registry - India?

What is the primary purpose of the Registry?

Why is it important to register clinical trials?

Is it mandatory to register a clinical trial?

Which clinical trials need to be registered?

When should trials be registered?

Who is responsible for registering a trial?

What is the procedure for registering a clinical trial?

What information is recorded in the Registry?

What is UTRN?

How can one access data of a registered trial?

Who all are involved in the CTRI?

The Clinical Trials Registry - India (CTRI) is a free and searchable on-line register of all clinical trials being conducted in India. Other countries, which do not have the facilities of such registration, may also register their clinical trials here. To register their clinical trials, trial lists have to declare certain items pertaining to their clinical trials (as mentioned in data set) before the enrollment of the first patient in the clinical trial. Registration in the CTRI is free of cost. The Registry has been initiated at the National Institute of Medical Statistics (ICMR), New Delhi, with funding from Department of Science and Technology, Indian Council of Medical Research and the World Health Organization. The management team is led by Professor Arvind Pandey.

The primary purpose is to make information regarding clinical trials being conducted in India freely available to anyone who desires the information. Through the Registry, information of all clinical trials taking place across the country in all areas of health - new drugs, treatments, therapies, surgical procedures and new medical devices will become publicly available for the first time.

It is important to register clinical trials for both ethical and scientific reasons. Registration of trials ensures transparency, accountability and accessibility of clinical trials and their results. Further, it promotes greater trust and public confidence in clinical research. Trial registration also helps to prevent bias generated by selective reporting of only "positive" findings as well as reduce unnecessary duplication of research through greater awareness of existing trials and results.

As of the present moment, registration is purely voluntary; however, registration is likely to have a lot of advantages both for the registrant as well as the public. Further, prior registration is now a condition of publishing clinical trial data. From 1st July 2005 the International Committee of Medical Journal Editors (ICMJE) have declared that their journals will not publish the results of any clinical trials not included on an authorised register at the trials inception.

All interventional clinical trials conducted in India and involving Indian participants need to be registered. An interventional clinical trial is any research study that prospectively assigns people to one or more health-related interventions (e.g., preventive care, drugs, surgical procedures, behavioral treatments, etc.) to evaluate their effects on health-related outcomes. Thus, early and late trials, trials of marketed or non-marketed products, randomized or non-randomized trials -- all should be registered.

Trials should be registered before the enrollment of the first patient.

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. However, in case of multi-country trials, the Indian PI should also get the trial registered in CTRI quoting any other Registration number as its Secondary ID.

Initially, a registrant will have to create a login name and password. This can be done by filling p the form that appears after clicking on the Register Trial button. Once all the mandatory information has been entered, the registrant should click the Submit button.
Following submission of the personal data, a password confirmation note to the email ID of the registrant will be sent. Thereafter the registrant can use the chosen Username and password to upload the required information on a clinical trial proposed to be conducted. A registrant may fill in the data set items at his or her own convenience by clicking on the save button. A registrant may then edit the fields as required or take a print out of the entered information by clicking on the Print button. The information filled in the fields of the data set items will not be available for the System Administrator till the registrant clicks on the Submit button. Once the data is submitted and until the trial is registered, any trial information is not available for editing by the registrant. Once the data is submitted, the CTRI staff will check the submitted information for completeness and whether informative entries have been provided. If needed, the registrant will be contacted for any queries. Further, the staff will verify that the trial is being conducted through contact with Ethics Committee.
Once queries, if any are clarified, the trial will be officially registered and allocated a unique registration number. Both the date of submission and date of registration will be recorded. Registrants are also required to regularly update information on each trial (including patient accrual, trial and publication status). Further, all the WHO fields need to be filled if the trial is to receive a registration number and fulfill WHO/ICMJE requirements. Incomplete entries will be given a provisional registration number that will not suffice for purposes of publication in journals that endorse the ICMJE recommendations for trial registration.
If all the necessary fields are filled with valid and informative entries, the trial will be officially registered and allocated a unique registration number. Trials which are not verifiable from relevant sources despite attempts to do so by the CTRI staff, but appear complete with respect to trial information is provided, the trial will be fully registered but a note will mention that it is “Not verified”

The following information is recorded in the Registry [for detailed information and explanation of each field click on Trial Registration Set ]:

• UTRN*


• Registration Number


• Trial Registration Date


• 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


• Name of Ethics Committee and approval status*


• Regulatory Clearance obtained from DCGI*


• Date of first enrollment


• Estimated duration of trial


• Target sample size


• Health Condition/Problem studied


• Intervention and Comparator agent


• Key inclusion/Exclusion Criteria


• Primary Outcome/s


• Secondary Outcome/s


• Countries of Recruitment


• Site/s of study


• Status of Trial*


• Phase of Trial*


• Study Type


• Brief Summary


• Method of generating randomization sequence


• Method of allocation concealment


• Blinding and masking

Items that are in Black are the WHO Data Set items while the ones in blue are additional requirements of the CTRI

The fields marked with * are mandatory for registration to proceed.

UTRN, or Unique Trial Reference Number, is a number assigned by the WHO by giving some preliminary information. To get this number click on the link given alongside the UTRN icon, which will take the registrant to the designated WHO site.

To search the list of registered trials click on the Trial Search button and then enter the key words of the trial to be searched. All data set items of registered trials will be made freely and publicly available.

The following members constitute the CTRI team

CTRI - Team

Chairman
Director General, ICMR, New Delhi

Vice Chairman
Prof. C.M. Gupta, Director, CDRI, Lucknow

Administrator
Prof. Arvind Pandey, Director, NIMS (ICMR), New Delhi

Advisor
Prof. S.D. Seth, Chair in Clinical Pharmacology, ICMR, New Delhi

Coordinator
Dr. Abha Rani Aggarwal, DD, NIMS (ICMR), New Delhi

Technical Working Group

Dr. Lalit Kant, Sr. DDG, ECD, ICMR, New Delhi
Prof. Arvind Pandey, Director, NIMS (ICMR), New Delhi
Dr. Vasantha Muthuswamy, Sr. DDG, BMS, ICMR, New Delhi
Prof. P. Tharyan, Deptt. of Psychiatry, CMC, Vellore
Prof. C.M. Pandey, SGPGI, Lucknow
Dr. Ambujam Nair Kapoor, DDG (SG), ICMR, New Delhi
Dr. Abha Rani Aggarwal, Coordinator, CTRI, NIMS, New Delhi
DST Representative, New Delhi
WHO Representative, New Delhi

 

Scientists

Dr. Atul Juneja, R.O., NIMS, New Delhi
Dr. Mohua Maulik, Res. Scientist, CTRI, NIMS, New Delhi
Ms. Jyotsna Gupta, Research Scientist -Gr.I, CTRI, NIMS, New Delhi
Mr. Yashmin Panchal, Reserach Scientist -IT Gr.II, CTRI, NIMS, New Delhi

Data Entry Operators

Mr. Lalit Parashar, CTRI, NIMS, New Delhi
Mr. Anoop Upadhyay, CTRI, NIMS, New Delhi
Ms. Noori Dua, CTRI, NIMS, New Delhi
Mr. Harish Kumar, CTRI, NIMS, New Delhi
Mr. Bir Singh, CTRI, NIMS, New Delhi

IT Development & Support

GovernIT, Kerala, India