India

India

Clinical Trials Registry - India (CTRI)

Verified on September 9, 2021

India has a primary registry, Clinical Trials Registry-India (CTRI). CTRI is a World Health Organization (WHO) recognized primary registry. It has provisions to publish protocol registrations, which is a mandatory requirement for clinical trials conducted in India. Currently, only protocols can be registered at their portal using WHO Trial Data Set (TRDS).

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
CTRI Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4)
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
CTRI Registration

Yes

Prior to Enrollment
Results

No

Not applicable (NA)

Registry Updates


  • June 2017: India Regulatory Update - June 30, 2017: According to the CTRI bulletin, all trials are flagged according to the status at the time of registration. For prospective registration at the time of trial submission, patient enrolment should not have begun. Otherwise, the trial will be flagged as ‘Trial Registered Retrospectively’. Once a trial is registered, flagging cannot be changed.

References


  1. Frequently Asked Questions. Clinical Trial Registry India. http://ctri.nic.in/Clinicaltrials/faq.php. Published September 22, 2018. Accessed October 22, 2018.