Guidelines for Pharmacovigilance Case Triage

1) Purpose

The purpose of this SOP is to establish procedures for the initial assessment and classification of incoming adverse event reports in pharmacovigilance.

2) Scope

This SOP applies to pharmacovigilance personnel responsible for triaging adverse event reports within the organization.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing Case Triage activities. PV staff involved in case triage are responsible for adhering to this SOP.

4) Procedure

4.1 Receipt of Adverse Event Reports

1. Receive adverse event reports through various channels, including healthcare professionals, consumers, clinical trials, and literature sources.
2. Ensure timely and accurate recording of incoming adverse event data into the pharmacovigilance database.

4.2 Initial Case Assessment

1. Conduct an initial assessment of each adverse event report to determine completeness and clarity of information.
2. Verify essential information such as patient demographics, reporter details, suspect product(s), and adverse event description.

4.3 Case Classification

1. Classify adverse event reports according to severity, seriousness criteria (e.g., death, hospitalization, congenital anomaly), and regulatory reporting requirements.
2. Assign appropriate case classification categories (e.g., serious, non-serious) based on predefined criteria and regulatory guidelines.

4.4 Prioritization of Cases

1. Prioritize adverse event reports for further evaluation and processing based on clinical significance, potential public health impact, and regulatory timelines.
2. Ensure urgent cases requiring immediate action (e.g., fatal outcomes, safety signals) are expedited for detailed assessment and reporting.

4.5 Case Documentation and Coding

1. Document case details, assessment findings, and classification decisions in the pharmacovigilance database or case management system.
2. Assign appropriate medical coding (e.g., Medical Dictionary for Regulatory Activities – MedDRA) to adverse events and product terms.

4.6 Communication and Follow-up

1. Communicate with relevant stakeholders, including healthcare professionals, regulatory authorities, and marketing authorization holders, as needed for additional information or clarification.
2. Follow up on incomplete or unclear adverse event reports to obtain necessary details for accurate assessment and reporting.

4.7 Documentation and Record Keeping

1. Maintain comprehensive records of case triage activities, including case processing logs, communication logs, and follow-up documentation.
2. Ensure that all documentation related to case triage is stored securely and is accessible for regulatory inspections and audits.

4.8 Training and Education

1. Provide training to PV staff on case triage procedures, regulatory requirements, and best practices for adverse event assessment and classification.
2. Ensure that PV team members are proficient in using pharmacovigilance databases, coding systems, and case management tools.

4.9 Continuous Improvement

1. Regularly review case triage processes and workflows based on feedback, regulatory changes, and quality assurance findings.
2. Implement improvements to enhance efficiency, accuracy, and consistency in adverse event reporting and case classification.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, MedDRA – Medical Dictionary for Regulatory Activities

6) Documents, if any

Case triage guidelines, adverse event reporting forms, communication templates, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.

8) SOP Version

Version 1.0