Standard Operating Procedure for Registration of BE Trials on CTRI
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/021/2025 |
| Supersedes | SOP/BA-BE/021/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standardized procedure for registering Bioequivalence (BE) trials on the Clinical Trials Registry – India (CTRI) platform, in compliance with Indian regulatory requirements prior to trial initiation.
2. Scope
This SOP applies to all BA/BE trials to be conducted in India and ensures timely and accurate submission of required information on the CTRI portal (www.ctri.nic.in).
3. Responsibilities
- Regulatory Affairs: Prepares, submits, and updates the CTRI application.
- Clinical Project Manager: Provides trial details, timelines, and ensures protocol compliance.
- Medical Writer: Provides the protocol synopsis and ethics details.
- Principal Investigator (PI): Verifies accuracy of site- and PI-specific details.
4. Accountability
The Head of Regulatory Affairs is accountable for ensuring registration of BE studies on CTRI before first subject enrollment as per Schedule Y requirements.
5. Procedure
5.1 Preparation for CTRI Registration
- Create a CTRI user account with PI’s institutional email ID.
- Collect the following documents:
- Final Protocol (PDF)
- Informed Consent Form (ICF)
- Investigator’s Brochure (IB)
- IEC approval letter (or submission acknowledgment if pending)
- Clinical Trial Insurance
- Verify completeness using Annexure-1: CTRI Registration Checklist.
5.2 Data Entry on CTRI Portal
- Log in to https://ctri.nic.in.
- Click “New Trial Registration” and fill out the online form:
- Public Title
- Scientific Title
- Primary Sponsor
- Trial Sites and PI Details
- Sample Size
- Intervention Details
- Phase (Phase I, BE, etc.)
- Ethics Committee and DCGI Details
- Upload required PDFs and save draft application.
5.3 Review and Final Submission
- Generate preview and share internally for review and approval.
- PI and sponsor sign off the final submission form (physical or digital).
- Submit the application and retain CTRI registration ID for tracking.
5.4 Post-Submission Actions
- Monitor application status:
- Under Review
- Query Raised
- Registered
- Address queries from CTRI within 3–5 working days.
- Update trial status (e.g., “Not Yet Recruiting”, “Recruiting”, “Completed”) throughout the study lifecycle.
- Maintain communication records in Annexure-2: CTRI Query & Update Tracker.
6. Abbreviations
- BE: Bioequivalence
- BA: Bioavailability
- CTRI: Clinical Trials Registry – India
- PI: Principal Investigator
- ICF: Informed Consent Form
- SOP: Standard Operating Procedure
7. Documents
- CTRI Registration Checklist – Annexure-1
- CTRI Query & Update Tracker – Annexure-2
8. References
- Schedule Y – Drugs and Cosmetics Rules
- ICMR Guidelines for Clinical Trials
- WHO Trial Registration Data Set (TRDS)
- CTRI User Manual – www.ctri.nic.in
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: CTRI Registration Checklist
| Document | Available (Y/N) | Remarks |
|---|---|---|
| Final Protocol | Yes | Version 2.0 |
| ICF (English + Local Language) | Yes | Hindi translation attached |
| Investigator Brochure | Yes | V1.0, March 2025 |
Annexure-2: CTRI Query & Update Tracker
| Date | CTRI Ref No. | Action/Update | Status | Remarks |
|---|---|---|---|---|
| 10/04/2025 | CTRI/2025/04/012345 | Submitted Final Form | Under Review | Awaiting registration |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial SOP | New Implementation | QA Head |
| 17/04/2025 | 2.0 | Updated to align with CTRI version upgrade | Regulatory Change | QA Head |