Clinical Trials Registry – India (CTRI) is a free, online, public record system or database, for the registration of clinical trials being conducted in India. As per the New Drugs and Clinical Trial Rules, 2019 and the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, it is mandatory to register all regulatory trials or studies in CTRI. Currently, (as of April 2018) trials are required to be registered prospectively i.e. before the enrolment of the first participant on CTRI.  While currently mandatory for only regulatory trials it is recommended (as a good practice) that all types of studies be registered with the CTRI – both regulatory and non-regulatory.

The editors of most of the major biomedical journals in India including ICMJE (International Committee of Medical Journal Editors), only consider trials for publication that are registered with the CTRI. The process of registration involves provision of information regarding the study, investigator(s), site(s), sponsor(s), ethics committees, regulatory clearances, disease/condition, type of study, methodology, outcomes, etc. – thus ensuring transparency and accountability via an authenticated database that is publically available.

ICMR has also signed a joint statement under the aegis of WHO for ‘public disclosure of results for all interventional trials’. This will further the endeavours of the authorities to improve data transparency in research. CTRI accepts all kinds of trials or studies ranging from those involving drugs, surgical procedures, devices, biomedical, educational, behavioural, public health intervention studies, observational, implementation research to preclinical studies of experimental therapeutics and preventives, AYUSH and post graduate thesis. Submission of Ethics Approval and approval from the DCGI (if applicable) are essential for registration with CTRI. CTRI also accepts registration of trials from other countries, provided the relevant ethics approval is in English.

Helpful links

Following are some links that provide detailed information regarding the CTRI registration process:

• CTRI homepage (also includes a eTutorial that explains the process of registration)
• Trial registration dataset and description
• The CTRI news bulletin page is a useful resource for general queries and recent updates.
• Trial search link
• CTRI publications page has many useful articles about the registration process.
• FAQ

References

• Clinical Trial Registry – India, ICMR – National Institute of Medical Statistics website (last accessed 06.03.2019).
• New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 01.04.2019).
• Vardhana Rao, M. V., Maulik, M., Gupta, J., Panchal, Y., Juneja, A., Adhikari, T., Pandey, A., Clinical Trials Registry – India: An overview and new developments, Indian Journal of Pharmacology, 2018, vol. 50, no. 4, pages 208-211, available online (last accessed on 26.02.2019).
• Joint Statement on Public Disclosure of Results from Clinical Trials, available online (last accessed on 26.02.2019).