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“headline”: “SOP for Safety Data Exchange with Global PV Systems (VigiBase Alignment)”,
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Standard Operating Procedure for Safety Data Exchange with Global PV Systems (VigiBase Alignment)

Purpose

The purpose of this SOP is to establish standardized procedures for the exchange of safety data with global pharmacovigilance (PV) systems, including VigiBase, the WHO global ICSR (Individual Case Safety Reports) database. This ensures international harmonization, timely reporting, and compliance with WHO pharmacovigilance expectations.

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

1. Safety Data Collection Log (Annexure-1)
2. Safety Data Validation Log (Annexure-2)
3. Safety Data Exchange Log (Annexure-3)
4. Safety Acknowledgment Log (Annexure-4)
5. Safety Archiving Log (Annexure-5)

References

• WHO – VigiBase
• ICH GCP Guidelines
• MedDRA – Medical Dictionary for Regulatory Activities

Version: 1.0

Approval Section

Annexures

Annexure-1: Safety Data Collection Log

Annexure-2: Safety Data Validation Log

Annexure-3: Safety Data Exchange Log

Annexure-4: Safety Acknowledgment Log

Annexure-5: Safety Archiving Log

Revision History

For more SOPs visit: Pharma SOP