How to Register a Clinical Trial in India: A Complete Step-by-Step Guide 

Clinical trial registration India involves a clear, regulated sequence that every sponsor must follow before enrolling participants. Under the New Drugs and Clinical Trials Rules (NDCT Rules), 2019, registration ensures transparency, participant protection, ethical oversight, and compliance with national and global publication standards. The steps below explain the complete process in simple, structured terms.

Strengthen early trial readiness with cleaner pre-screening workflows and organized participant intake through DecenTrialz

Why Clinical Trial Registration Is Required

Registration ensures:

• Transparency of study methods and objectives
• Participant safety and ethical oversight
• Prevention of duplicate studies
• Compliance with WHO and ICMJE journal requirements
• Public availability of essential trial information

Trials registered late may face publication barriers, regulatory concerns, or EC objections.

Key Authorities in the Registration Process

CTRI (Clinical Trials Registry–India)

Public registry for prospective trial registration.
Assigns a REF number immediately upon submission, and a CTRI Number after full review and approval.

Ethics Committee (EC/IRB)

Ensures participant rights and safety.
A dated EC approval letter is mandatory at CTRI submission.

CDSCO and DCGI

India’s national regulatory authority responsible for approving trials involving new drugs, regulated medical devices, and certain high-risk interventions.

Step-by-Step Registration Process for Sponsors

The steps below reflect NDCT Rules 2019, updated CDSCO processes, current CTRI expectations, and SUGAM portal requirements.

Step 1: Prepare the Clinical Trial Protocol

The protocol is the foundational document describing:

• Study purpose and design
• Eligibility criteria
• Number of participants
• Interventions
• Visit schedules and assessments
• Safety oversight strategy
• Data analysis plan
• Insurance and compensation provisions

Sponsor tasks:

• Finalize protocol with version number and date
• Ensure consistency across informed consent forms, case report forms, and all supporting documents

Step 2: Prepare Participant Documents

Participant-facing documents must be clear and easy to understand.

These include:

• Participant Information Sheet (PIS)
• Informed Consent Form (ICF)
• Translated versions (if required)

These documents must explain:

• Purpose
• Procedures
• Risks and benefits
• Voluntary nature of participation
• Privacy protection
• Compensation for study-related injury

Step 3: Submit the Study to the Ethics Committee (EC/IRB)

The EC/IRB reviews:

• Protocol
• PIS/ICF
• Investigator’s Brochure
• Case report forms
• Site suitability details
• Investigator CVs
• Insurance and compensation documents

Regulation Update

Under NDCT Rule 19(5), EC review may occur in parallel with CDSCO review, but:

• CTRI requires dated EC approval letters at the time of submission, and
• CDSCO issues final permission only after EC approval.

Timeline: Commonly 2–6 weeks, depending on EC schedules.

Sponsor tasks:

• Ensure EC approval letters contain correct protocol title, version, site name, and approval date
• Maintain approvals for all participating sites

Step 4: Determine Whether CDSCO Approval Is Required

A corrected and accurate decision table for 2025:

Scenario	CDSCO Approval Required?	Notes
New drug / Investigational New Drug (IND)	✔ Yes	Requires Form CT-04 via SUGAM
Global clinical trial where product is IND or regulated	✔ Yes	IND/global new drug studies require CDSCO approval
Global trial using an approved, marketed drug without new claims	✖ Often Not Required	Purely post-marketing observational global studies may be exempt
Bioavailability / Bioequivalence (BA/BE) study of regulated drug	✔ Yes	45-day review timeline
Medical device trial (regulated categories)	✔ Yes	As per device risk class
Pure observational study with no intervention	✖ Not Required	CTRI still encourages registration when unclear

CDSCO Submission Includes:

• Application via SUGAM Portal
• Form CT-04 (for permission to conduct a clinical trial)
• Fee payment through Bharatkosh
• Protocol + Investigator’s Brochure
• CMC and safety data (if applicable)
• Preclinical or prior clinical data
• EC approval before final permission
• PI and site information
• Compensation and insurance documentation

CDSCO Review Timelines (NDCT Rules)

• New drug clinical trials: Up to 90 days
• BA/BE studies: Up to 45 days

Sponsor tasks:

• Register on SUGAM with Digital Signature Certificate
• Upload documents in required formats
• Respond promptly to CDSCO queries

Step 5: Collect All CTRI-Required Information

Information needed for CTRI:

• Study titles
• Health condition
• Study type and design
• Phase of study
• Inclusion/exclusion criteria
• Objectives and outcome measures
• Sample size (total + per site)
• Recruitment timelines
• PI and site details
• Dated EC approval letters
• CDSCO approval details (if applicable)
• Sponsorship details

Documents needed:

• EC approval letter(s) (dated and signed)
• CDSCO approval letter (if required)
• Final protocol
• PIS and ICF
• Investigator CVs
• Insurance and compensation documents

Step 6: Create a CTRI Account

Actions include:

• Register on ctri.nic.in 
• Provide PI or responsible contact details
• Verify email
• Access the online registration form

No fee is charged.

Step 7: Complete the CTRI Registration Form

CTRI requires precise, consistent information.

Important expectations:

• Titles must match EC approval exactly
• Site list must match EC-approved sites
• Study phase must reflect protocol and regulatory approvals
• Interventions must be described clearly without promotional wording
• Recruitment dates must be realistic and consistent
• Observational studies with even minimal intervention elements must still register

CTRI Timeline

• REF number assigned immediately after submission
• Review usually starts within 10 working days
• CTRI number assigned after clarifications and approval

Sponsor tasks:

• Conduct a complete internal quality check
• Fix inconsistencies in names, dates, or versions
• Respond quickly to CTRI clarifications

Step 8: Post-Approval Responsibilities

Once approved:

• CTRI number becomes public
• Enrollment can begin (if CDSCO and EC approvals are active)

Updating CTRI

Updates require contacting CTRI at ctri@gov.in to unlock the record.

Updates needed for:

• Adding or removing sites
• Changing investigators
• Amendments to protocol
• Recruitment status updates
• Timeline extensions

Additional Sponsor Responsibilities (NDCT Rules)

• Report Serious Adverse Events (SAEs) within 14 days to EC and CDSCO
• Maintain insurance coverage and compensation compliance
• Ensure all amendments receive EC approval

Expected Timelines 

Step	Expected Timeline
Protocol preparation	~1–3 weeks
EC/IRB approval	~2–6 weeks
CDSCO approval (new drugs)	Up to 90 days
CDSCO approval (BA/BE)	Up to 45 days
CTRI review	~10 days initial + time for clarifications

Common Mistakes Sponsors Should Avoid

• Submitting CTRI form without dated EC approval letters
• Assuming global trials always require CDSCO approval
• Using different protocol titles across EC, CDSCO, and CTRI
• Selecting incorrect study design or phase
• Uploading outdated protocol or ICF versions
• Entering site names not listed in EC approval
• Delayed responses to CTRI or CDSCO clarifications
• Failing to update CTRI after amendments

Avoiding these mistakes prevents delays and ensures smooth regulatory compliance.

Final Summary: A Clean Sponsor Roadmap

1. Finalize protocol and participant documents
2. Submit to EC for approval (parallel CDSCO review allowed under Rule 19(5))
3. Determine CDSCO need using the corrected IND-based criteria
4. Submit Form CT-04 via SUGAM if required
5. Gather all CTRI-required documents including dated EC letters
6. Create CTRI account
7. Submit CTRI form and receive REF number
8. Respond to CTRI clarifications and receive CTRI number
9. Update CTRI through email unlock requests when needed

This end-to-end process creates a fully compliant pathway for clinical trial registration in India, ensuring ethical conduct, regulatory readiness, and participant protection.

DecenTrialz: Supporting Early Trial Readiness 

DecenTrialz does not file EC submissions, CDSCO applications, or CTRI registrations.
Those responsibilities remain with the sponsor.

However, many registration challenges come from:

• Inconsistent eligibility criteria
• Unclear participant-facing materials
• Misaligned workflows between protocol and operations
• Poor documentation structure
• High screen failure rates due to unclear pre-screening

DecenTrialz strengthens early trial readiness by helping sponsors:

• Translate protocol eligibility into structured digital pre-screeners
• Ensure participant-facing materials are consistent
• Reduce mismatches between protocol text and operational workflows
• Organize participant information for cleaner site review
• Deliver only pre-qualified participants once recruitment begins

This improves study startup efficiency and prevents avoidable screen failures.

Improve Trial Readiness

Ensuring clear eligibility criteria and well-organized participant workflows makes the EC, CDSCO, and CTRI process far smoother.

Enhance your trial readiness with DecenTrialz:

Learn More: www.decentrialz.com
Contact the Team: www.decentrialz.com/contact