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)||
|Registration and Results Requirements|
|Prior to Enrollment|
|Not applicable (NA)|
- 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.