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“headline”: “SOP for Remote/Central SDV for Decentralized Trials”,
“description”: “This SOP defines standardized procedures for remote and central source data verification (SDV) in decentralized clinical trials. It ensures compliance with FDA, EMA, CDSCO, WHO, and ICH GCP, covering secure data access, monitoring, audit trails, privacy, and inspection readiness.”,
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Published on 21/12/2025
Standard Operating Procedure for Remote/Central SDV for Decentralized Trials
| SOP No. | CR/OPS/122/2025 |
| Supersedes | NA |
| Page No. | 1 of 66 |
| 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 remote and central source data verification (SDV) in decentralized clinical trials.
Scope
This SOP applies to sponsors, CROs, investigators, monitors, data managers, and QA staff involved in decentralized clinical trials. It covers processes for remote access to source data, central monitoring workflows, data verification, audit trails, and regulatory inspection readiness.
Responsibilities
- Sponsor: Provides oversight, ensures technology compliance, and approves monitoring plans.
- Investigator: Grants secure access to source data and ensures subject confidentiality.
- Monitor: Conducts remote SDV and documents findings in monitoring reports.
- CRO: Manages monitoring platforms and coordinates with sites.
- QA: Audits remote SDV processes and ensures compliance with regulations.
Accountability
The Sponsor’s Clinical Data Management Head is accountable for remote and central SDV oversight. Investigators are accountable for ensuring data accuracy and access compliance at site level.
Procedure
1. Planning and Preparation
1.1 Develop a monitoring plan specifying remote and central SDV procedures.
1.2 Document in Remote Monitoring Plan Log (Annexure-1).
2. Secure Data Access
2.1 Provide authorized monitors with role-based secure access to EHRs and eSource systems.
2.2 Maintain access details in Secure Access Log (Annexure-2).
3. Source Data Verification (SDV)
3.1 Verify subject-level data (e.g., demographics, visit dates, lab results) remotely.
3.2 Document findings in Remote SDV Log (Annexure-3).
4. Central Monitoring
4.1 Conduct data trend analysis across multiple sites.
4.2 Identify outliers or protocol deviations.
4.3 Document in Central Monitoring Log (Annexure-4).
5. Data Privacy and Confidentiality
5.1 Comply with GDPR, HIPAA, and local data protection rules.
5.2 Mask identifiers where possible.
5.3 Maintain entries in Data Privacy Compliance Log (Annexure-5).
6. Audit Trail and Documentation
6.1 Maintain audit trails of all remote access and SDV activities.
6.2 Record in Audit Trail Log (Annexure-6).
7. Reporting
7.1 Generate remote monitoring reports within 10 working days of activity.
7.2 File in TMF and ISF.
8. Inspection Readiness
8.1 Ensure all SDV records are inspection-ready.
8.2 Document inspection simulations in Inspection Readiness Log (Annexure-7).
Abbreviations
- SOP: Standard Operating Procedure
- SDV: Source Data Verification
- CRO: Contract Research Organization
- QA: Quality Assurance
- EHR: Electronic Health Record
- TMF: Trial Master File
- ISF: Investigator Site File
- GCP: Good Clinical Practice
- GDPR: General Data Protection Regulation
- HIPAA: Health Insurance Portability and Accountability Act
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
- CDSCO: Central Drugs Standard Control Organization
Documents
- Remote Monitoring Plan Log (Annexure-1)
- Secure Access Log (Annexure-2)
- Remote SDV Log (Annexure-3)
- Central Monitoring Log (Annexure-4)
- Data Privacy Compliance Log (Annexure-5)
- Audit Trail Log (Annexure-6)
- Inspection Readiness Log (Annexure-7)
References
- FDA – Guidance on Remote Monitoring
- EMA – Remote Monitoring Guidance
- CDSCO – Remote SDV in Decentralized Trials
- ICH GCP – Data Monitoring and Verification
- WHO – Decentralized Trials Monitoring
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Clinical Data Manager |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: Remote Monitoring Plan Log
| Date | Protocol ID | Prepared By | Status |
|---|---|---|---|
| 01/09/2025 | DEC-TRIAL-01 | Monitor | Approved |
Annexure-2: Secure Access Log
| Date | User ID | System Accessed | Role | Status |
|---|---|---|---|---|
| 02/09/2025 | MON-01 | EHR System | Monitor | Active |
Annexure-3: Remote SDV Log
| Date | Subject ID | Data Verified | Verified By | Status |
|---|---|---|---|---|
| 03/09/2025 | S101 | Visit 1 Labs | Monitor | Confirmed |
Annexure-4: Central Monitoring Log
| Date | Analysis Performed | Reviewed By | Status |
|---|---|---|---|
| 04/09/2025 | Protocol Deviation Trends | Data Manager | Reviewed |
Annexure-5: Data Privacy Compliance Log
| Date | System | Measure | Reviewed By | Status |
|---|---|---|---|---|
| 05/09/2025 | EHR System | Encryption | QA Officer | Compliant |
Annexure-6: Audit Trail Log
| Date | User ID | Activity | System | Status |
|---|---|---|---|---|
| 06/09/2025 | MON-01 | SDV Completed | EHR System | Logged |
Annexure-7: Inspection Readiness Log
| Date | Agency | Simulation | Performed By | Status |
|---|---|---|---|---|
| 07/09/2025 | EMA | Mock Inspection | QA Team | Completed |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP