{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-safety-data-exchange-with-global-pv-systems-vigibase-alignment”
},
“headline”: “SOP for Safety Data Exchange with Global PV Systems (VigiBase Alignment)”,
“description”: “This SOP defines procedures for safety data exchange with global pharmacovigilance (PV) systems, including VigiBase. It ensures compliance with WHO expectations, timely adverse event reporting, and harmonization of safety data across international databases.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}
Published on 21/12/2025
Standard Operating Procedure for Safety Data Exchange with Global PV Systems (VigiBase Alignment)
| SOP No. | CR/OPS/150/2025 |
| 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 exchange of safety data
Scope
This SOP applies to sponsors, CROs, pharmacovigilance staff, investigators, and regulatory affairs teams involved in global safety reporting for clinical trials. It covers safety data collection, formatting, validation, exchange with VigiBase, and record-keeping in TMF and safety databases.
Responsibilities
- Sponsor: Ensures timely safety data submissions to global PV systems including VigiBase.
- CRO: Coordinates data exchange and ensures accuracy of submissions.
- PV Department: Prepares and validates ICSRs for electronic submission.
- Investigator: Provides complete and accurate SAE/SUSAR reports.
- QA: Audits safety reporting records for accuracy and compliance.
Accountability
The Sponsor’s Pharmacovigilance Head is accountable for ensuring compliance with WHO safety data exchange requirements and proper alignment with VigiBase.
Procedure
1. Data Collection
1.1 Collect SAE, SUSAR, and other safety data from investigators.
1.2 Verify completeness using ICH E2B(R3) standards.
1.3 Record in Safety Data Collection Log (Annexure-1).
2. Data Validation
2.1 Perform quality checks for completeness and consistency.
2.2 Ensure coding with MedDRA dictionary.
2.3 Record in Safety Data Validation Log (Annexure-2).
3. Data Exchange
3.1 Submit validated ICSRs to VigiBase via national PV center or WHO PV platform.
3.2 Document submission details in Safety Data Exchange Log (Annexure-3).
4. Acknowledgment and Tracking
4.1 Track acknowledgment receipts from VigiBase.
4.2 Document in Safety Acknowledgment Log (Annexure-4).
5. Archiving
5.1 Archive safety submissions and acknowledgments in TMF.
5.2 Document archiving details in Safety Archiving Log (Annexure-5).
Abbreviations
- SOP: Standard Operating Procedure
- PV: Pharmacovigilance
- WHO: World Health Organization
- ICSR: Individual Case Safety Report
- SAE: Serious Adverse Event
- SUSAR: Suspected Unexpected Serious Adverse Reaction
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- MedDRA: Medical Dictionary for Regulatory Activities
Documents
- Safety Data Collection Log (Annexure-1)
- Safety Data Validation Log (Annexure-2)
- Safety Data Exchange Log (Annexure-3)
- Safety Acknowledgment Log (Annexure-4)
- Safety Archiving Log (Annexure-5)
References
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, PV Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Pharmacovigilance |
Annexures
Annexure-1: Safety Data Collection Log
| Date | Subject ID | Event | Reported By | Status |
|---|---|---|---|---|
| 01/09/2025 | SUB-301 | Severe Headache | Investigator | Collected |
Annexure-2: Safety Data Validation Log
| Date | ICSR ID | Validation Performed By | Status |
|---|---|---|---|
| 02/09/2025 | ICSR-2025-01 | PV Officer | Validated |
Annexure-3: Safety Data Exchange Log
| Date | ICSR ID | Submitted To | Submitted By | Status |
|---|---|---|---|---|
| 03/09/2025 | ICSR-2025-01 | VigiBase | PV Specialist | Submitted |
Annexure-4: Safety Acknowledgment Log
| Date | ICSR ID | Acknowledgment Received | Verified By | Status |
|---|---|---|---|---|
| 04/09/2025 | ICSR-2025-01 | Yes | QA | Confirmed |
Annexure-5: Safety Archiving Log
| Date | ICSR ID | Archived By | Location | Status |
|---|---|---|---|---|
| 05/09/2025 | ICSR-2025-01 | QA Officer | TMF | Archived |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Pharmacovigilance |
For more SOPs visit: Pharma SOP