Clinical Trail Registration Procedure in India (CTRI Website)
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.
CTRI - Clinical Trail Registration Procedure is explained below,
1. First Register with CTRI website to create your profile or account
Note: To make your new CTRI registration follow this link - Click Here
2. A new clinical trail registration can be included as per the data set requested by CTRI
Note: CTRI Data set and its descriptions detailed- Click Here
3. Prepare a dataset of your trial and submit to CTRI.
4. After submission of your trail a reference number will be given by CTRI.
5. CTRI checks the submitted dataset and sends back trial for clarification/modification if found incomplete/inappropriate. Note: Follow the CTRI notifications to clarify if any discrepancies etc.
6. CTRI verifies the trial from “Principal Investigator, contact person of scientific and public query” (who can be the same or different individuals).
7. A unique registration number is provided to the trial once found complete and verified. This registration number needs to be stated while submission of the study in any journal.
8. You can find your clinical trail related information by making the advanced search in CTRI portal - Click Here
Important Information - CTRI Registration
For postgraduate thesis: The concerned guide of postgraduate thesis should account as the PI while registering.
Your Trail will be considered as incomplete if the scanned Ethical Committee Letter is not enclosed.
The study title should be easy to understand using simple words and abbreviations.
“Secondary id” is any number associated with the trial, for example, the number of an already registered multi-centric trial in another registry (Universal Trial Number UTN) or protocol number. It is not a mandatory section.
If the study is an academic exercise (investigator-initiated trials), the source of monetary/material support should be acknowledged as “Institutional”
Primary sponsor may or may not be the funding agency, but it is responsible for initiation, conduct, and management of the study. e.g., the investigator in an investigator-initiated trial can be the primary sponsor.
It is the responsibility of the sponsor to ascertain whether DCGI approval is required or not.
International Non-proprietary Name (INN) is to be used if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable. For each intervention, description of other intervention details should be provided (e.g., dose, duration, mode of administration).
Most importantly, registering once is not the end of the exercise and data (e.g., recruitment status, results, adverse events) are to be updated in the registry time to time as the trial progresses.