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“headline”: “SOP for Multi-Regional Clinical Trials (ICH E17)”,
“description”: “This SOP defines the process for conducting multi-regional clinical trials (MRCTs) in compliance with ICH E17 guidelines. It ensures harmonized trial design, operational oversight, and regulatory alignment across multiple geographic regions.”,
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Published on 23/12/2025
Standard Operating Procedure for Multi-Regional Clinical Trials (ICH E17)
| SOP No. | CR/OPS/155/2025 |
| Supersedes | NA |
| Page No. | X of Y |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to establish standardized procedures for the design, conduct, and oversight of Multi-Regional Clinical Trials (MRCTs) in accordance with ICH E17 guidelines. MRCTs are critical
Scope
This SOP applies to sponsors, CROs, investigators, QA, regulatory affairs, and clinical operations staff involved in MRCT planning and execution. It covers trial design, harmonization of endpoints, regional regulatory alignment, subject recruitment, monitoring, and documentation practices.
Responsibilities
- Sponsor: Ensures global coordination, protocol harmonization, and regulatory strategy alignment.
- CRO: Implements MRCT operations and manages region-specific logistics.
- Investigator: Conducts trial activities in compliance with harmonized protocol.
- QA: Conducts global audits and verifies adherence to MRCT requirements.
- Regulatory Affairs: Coordinates submissions across multiple regions.
Accountability
The Sponsor’s Global Clinical Operations Head is accountable for ensuring MRCT design, execution, and reporting are compliant with ICH E17 and regional requirements.
Procedure
1. MRCT Design
1.1 Incorporate ICH E17 principles into protocol design.
1.2 Define global and regional objectives.
1.3 Record design considerations in MRCT Design Log (Annexure-1).
2. Endpoint Harmonization
2.1 Establish globally relevant and regionally sensitive endpoints.
2.2 Document endpoint harmonization in Endpoint Log (Annexure-2).
3. Regional Regulatory Alignment
3.1 Engage with regulatory authorities in all participating regions.
3.2 Document regulatory interactions in Regional Regulatory Log (Annexure-3).
4. Subject Recruitment and Diversity
4.1 Implement strategies to ensure inclusion of diverse populations.
4.2 Track enrollment data in Recruitment Diversity Log (Annexure-4).
5. Oversight and Monitoring
5.1 Ensure global monitoring consistency across regions.
5.2 Record oversight activities in MRCT Oversight Log (Annexure-5).
6. Data Pooling and Reporting
6.1 Pool data across regions for integrated analysis.
6.2 Ensure regional differences are accounted for.
6.3 Document in MRCT Data Pooling Log (Annexure-6).
Abbreviations
- SOP: Standard Operating Procedure
- MRCT: Multi-Regional Clinical Trial
- ICH: International Council for Harmonisation
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- ISF: Investigator Site File
Documents
- MRCT Design Log (Annexure-1)
- Endpoint Log (Annexure-2)
- Regional Regulatory Log (Annexure-3)
- Recruitment Diversity Log (Annexure-4)
- MRCT Oversight Log (Annexure-5)
- MRCT Data Pooling Log (Annexure-6)
References
- ICH E17 – General Principles for Planning and Design of MRCTs
- ICH GCP Guidelines
- FDA Guidance on MRCTs
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Global Trial Coordinator |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Global Clinical Operations |
Annexures
Annexure-1: MRCT Design Log
| Date | Protocol ID | Design Consideration | Prepared By | Status |
|---|---|---|---|---|
| 01/09/2025 | MRCT-2025-01 | Global + Regional Objectives Defined | Clinical Ops | Completed |
Annexure-2: Endpoint Log
| Date | Endpoint | Global/Regional | Prepared By | Status |
|---|---|---|---|---|
| 03/09/2025 | Primary Efficacy Endpoint | Global | Reg Affairs | Approved |
Annexure-3: Regional Regulatory Log
| Date | Region | Authority | Interaction | Status |
|---|---|---|---|---|
| 05/09/2025 | EU | EMA | Scientific Advice | Completed |
Annexure-4: Recruitment Diversity Log
| Date | Region | Enrollment % | Diversity Action | Status |
|---|---|---|---|---|
| 07/09/2025 | Asia | 30% | Target Recruitment Expanded | Ongoing |
Annexure-5: MRCT Oversight Log
| Date | Activity | Region | Performed By | Status |
|---|---|---|---|---|
| 10/09/2025 | Monitoring Review | North America | CRO | Compliant |
Annexure-6: MRCT Data Pooling Log
| Date | Protocol ID | Data Pooling Activity | Prepared By | Status |
|---|---|---|---|---|
| 12/09/2025 | MRCT-2025-01 | Regional Data Integrated | Data Manager | Completed |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Global Clinical Operations |
For more SOPs visit: Pharma SOP