How to register a Clinical Trial with CTRI (Clinical Trial Registry – India) – part 1

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ctri

The Clinical Trial Registry – India (CTRI) is hosted at Indian Council of Medical Research’s (ICMR) National Institute of Medical Statistics (NIMS.) An Indian repository for information on the Clinical Trials conducted in India, CTRI is a comprehensive database that provides information in an easily accessible format to the general public.

The information for registration is contained in an extensive data set. The data set consists of 8 parts which have mandatory sections before being submitted to CTRI.

This tutorial is a step by step guideline to registering your clinical trial on CTRI.

Step 1: Go to http://ctri.nic.in/Clinicaltrials/login.php for the CTRI Website.

Step 2: Click “New applicant” from the top left corner and fill in your details to register your profile.

Step 3: Once your profile is verified and approved, you get to use your Username & Password to log into the CTRI application centre.

The main shows you the following

  1. Trials for Modification/Clarification
  2. Registered Trials
  3. General Query
  4. An option to edit your profile
  5. There is also a small statistic showing you the number of trials in various stages of registration for your profile.

Step 4: Click on the button that says “Add new Trial” This allows you to enter the title of the clinical study. (Both Public and Scientific Title)

Step 5: Once this is entered, a new trial entry is allowed and this directs you to your main page again.

Step 6: Now the main page gives you the option to “Update/Delete” this entry. When you click on Update the website takes you through a series of forms in EIGHT PARTS  before you can submit your trial to CTRI for verification and approval.

Step 7: The trial registration process also requires that you upload documents – Ethics Committee approval letter as well as DCGI clearance as applicable.

Step 8: Once the details are filled out, you can submit the same to CTRI.

Step 9: Upon returning to your main page, you will notice that the page shows you the title of you clinical study – “Trials under review/entry”

Step 10: The space will also show your a unique reference number after submission, once the trial is approved, a unique CTRI Number is allotted to the same.

Step 11: Interim, in the event that the CTRI administrators have any query about the submission, a clarification for the same is raised. This is also intimidated via email to the person listed under “Scientific Query” and “Public Query”

Step 12: Queries to be answered/resolves satisfactorily before the trial can be registered with the CTRI.

The advantage of registering with the CTRI is the it is one of registries associated with World Health Organisation (WHO’s) International Clinical Trial Registry Platform. This allows people from all over the world to access salient information about your clinical study using the international ICTRP portal.

 

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