If you are planning a clinical trial in India, you probably heard about CTRI registration. It’s mandatory for all trials involving human participants.
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Managed by ICMR-National Institute of Medical Statistics, CTRI ensures transparency, accountability, and safety in clinical research.
The good part? As of 2026, the process is fully online and free of charge.
Pre-Registration Checklist
Before you start, make sure you have everything ready. Prospective registration is mandatory, meaning you must register before enrolling the first participant.
Here’s what you need:
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Ethics Committee (EC) Approval – Scanned PDF of the approval letter. EC must be registered with CDSCO/DHR.
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DCGI Approval – Needed if your trial involves new drugs, biologicals, or medical devices (regulatory trials).
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Trial Protocol – Summary of study design, inclusion/exclusion criteria, and outcomes.
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Contact Details – Active email IDs for:
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Principal Investigator (PI)
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Scientific Query Contact
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Public Query Contact
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Step-by-Step Registration Process
Account Creation
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Go to the official portal: ctri.nic.in
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Click “New Applicant” to create a user profile.
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Important: If you’re registering on behalf of a company, use the company’s name for the account — not an individual’s — to avoid transfer problems later.
Adding a New Trial
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Once logged in, click “Add New Trial”.
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The form has 8 parts based on the WHO 20-item dataset:
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Parts 1–3: Basic details like public/scientific titles, trial ID, PI details.
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Parts 4–6: Study design, interventions, and trial site information.
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Parts 7–8: Upload EC/DCGI approvals and do a final review.
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Submission & Reference Number
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Click Submit after filling all parts.
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You’ll get a Reference Number (REF) — this is a tracking ID, not the final registration number.
Verification (Crucial Step)
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CTRI will send verification emails to the PI and the scientific/public contacts.
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Important: Your trial won’t move to review unless everyone clicks the verification link.
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Most delays happen because of wrong email IDs, so double-check them.
Final Approval
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After verification and internal review, CTRI assigns a CTRI Number (e.g., CTRI/2026/01/XXXXXX).
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You need this number for journal publications.
Key 2026 Updates & Guidelines
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CRO Registration: Clinical Research Organizations (CROs) must now be registered with the Central Licensing Authority (Form CT-07B).
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Mandatory Updates: You must update your trial status (e.g., “Not yet recruiting” → “Open to recruitment”) and provide updates every 6 months.
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PG Thesis Trials: Post-graduate students must register their thesis trials. Both the student and the guide need to be listed with official department addresses.
Final Tips
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Keep all your documents scanned and ready before starting.
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Always use official email IDs to avoid verification delays.
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Save your REF number after submission for future reference.
Official Portal for Registration: https://ctri.nic.in