Guidelines for Pharmacovigilance Adverse Drug Reaction (ADR) Reporting
1) Purpose
The purpose of this SOP is to outline procedures for the reporting of adverse drug reactions (ADRs) associated with pharmaceutical products.
2) Scope
This SOP applies to all pharmacovigilance personnel responsible for ADR reporting, including pharmacovigilance managers, safety scientists, and clinical research associates.
3) Responsibilities
The ADR Reporting Team is responsible for timely identification, assessment, documentation, and reporting of ADRs in compliance with regulatory requirements. The Pharmacovigilance (PV) Manager oversees ADR reporting activities to ensure patient safety and regulatory compliance.
4) Procedure
4.1 ADR Identification and Documentation
- Receive and document ADR reports from clinical trials, spontaneous reports, literature, and other sources.
- Classify ADRs based on severity, seriousness criteria, and regulatory reporting requirements.
- Enter ADR data into the pharmacovigilance database for further assessment.
4.2 ADR Assessment and Causality Analysis
- Assess ADRs to determine the causal relationship between the pharmaceutical product and the reported event.
- Conduct medical review and analysis of available data, including patient medical history and concomitant medications.
- Document causality assessment findings and decisions.
4.3 Reporting and Communication
- Prepare and submit individual case safety reports (ICSRs) to regulatory authorities as per reporting timelines and requirements.
- Communicate ADR findings and updates to relevant stakeholders, including clinical investigators and regulatory agencies.
- Ensure accurate and
4.4 Follow-up and Documentation
- Monitor follow-up activities related to reported ADRs, including additional information requests and patient outcome assessments.
- Update ADR records with new information and outcomes as they become available.
- Document all follow-up activities and communications for audit and inspection purposes.
4.5 Quality Control and Continuous Improvement
- Implement quality control checks to ensure accuracy and completeness of ADR data and reporting.
- Review ADR reporting processes and identify opportunities for process improvement.
- Participate in training and development activities to enhance ADR reporting competencies.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, ADR – Adverse Drug Reaction, ICSR – Individual Case Safety Report
6) Documents, if any
ADR reports, individual case safety reports (ICSRs), follow-up documentation.
7) Reference, if any
ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.
8) SOP Version
Version 1.0
