This document outlines the requirements and process for clinical trial registration in India. It discusses the goals of the Clinical Trial Registry of India (CTRI), including improving transparency, validity, ethics, and results reporting. The CTRI is hosted by the National Institute of Medical Statistics and registers all clinical trials conducted in India. Trial registration involves submitting key trial details before patient enrollment and obtaining necessary approvals. Primary registries include those of India, New Zealand, China, and Sri Lanka.

1. CLINICAL TRIALS
REGISTRATION IN INDIA

2. REQUIREMENT FOR TRIALS
REGISTRATION

3. VISION
• Improve transparency and accountability
• Improve the internal validity of trials
• Conform to accepted ethical standards
• Reporting of all relevant results of
registered trials

4. CTRI
• Set up at theNational Instituteof Medical
Statistics(NIMS), ICMR, New Delhi
• Freeand onlinesystem for registration all
clinical trialsbeing conducted in India
• Launched on 20th
July 2007
• Initiated asavoluntary measure, since15th
June2009
• Trial registration in theCTRI hasbeen made

5. What istheInternational Clinical
TrialsRegistry Platform?
• Network of Primary and Secondary Registers
• Developed by theWHO
• Ensure that a complete view of research is
accessible to all those involved in health care
decision making
• Is not a Registry, but collects data (details of
registered trials) from its Primary Registers
and displaysthem from asinglesearch portal

6. PRIMARY REGISTRIESAND PARTNER
REGISTRIES
• A Primary Registry in the WHO Registry
Network is a clinical trial registry with at least
a national remit that meets WHO Registry
Criteria for content, quality and validity,
accessibility, unique identification, technical
capacity and governanceand administration
• Currently 11 Primary Registries in the WHO
Registry Network, including theCTRI.

7. • Primary Registries:
India, New Zealand, China, Srilanka, Australia
• Partner Registries:
USA, European Union

8. WHICH TRIALSGET
REGISTERED???
• Drugs, surgical procedures, preventive
measures, lifestyle modifications, devices,
educational or behavioral treatment,
rehabilitation strategies strategies as well as
trials being conducted in the purview of the
Department of AYUSH
• Beforeenrolment of thefirst participant.

9. TRIAL REGISTRATION
INVOLVES. . .
• Public declaration and identification of trial
investigators, sponsors, interventions, patient
population etc before the enrollment of the
first patient.
• Submission of Ethics approval and DCGI
approval (if applicable) is essential for trial
registration in theCTRI.

10. INFORMATION REQUIRED FOR
REGISTRATION
• Public titleof study
• Scientific titleof study
• Secondary IDs, if any
• Principal Investigator’snameand address
• Contact person (Scientific Query)
• Contact person (Public Query)
• Source/sof monetary or material support
• Primary and Secondary sponsor
• Countriesof recruitment

11. • Nameof EthicsCommitteeand approval status
• Regulatory clearanceobtained from DCGI
• Health condition/problem studied
• Study type
• Intervention and comparator agent
• Inclusion/Exclusion criteria
• Method of generating randomization sequence
• Method of allocation concealment
• Blinding/masking

12. • Target samplesize
• Phaseof trial
• Dateof first enrollment
• Estimated duration of trial
• Recruitment statusof trial
• Brief Summary

13. AFTER TRIAL REGISTRATION
• CTRI scientists review the trial data set for
meaningful and relevant entries
• In case of any discrepancies or concerns, the
trial may besent back to theRegistrant
• Editing possible
• Upon satisfaction of theabovecriteria, thetrial
is registered and trial details viewable from the
public domain

14. Clinical Trials Registry – India
National Instituteof Medical Statistics
Indian Council of Medical Research
Ansari Nagar
New Delhi-110029
India
Tel: 011-26588725; 011-26588803
Email: ctr.nims@gmail.com

15. REFERENCES
• www.ctri.nic.in
• http://indianmedicine.nic.in/

16. “Theonly way to do great work is
to lovewhat you do. If you haven’t
found it yet, keep looking. Don’t
settle.”
– SteveJobs