Guidelines for Assessing Pharmacovigilance Cases

1) Purpose

The purpose of this SOP is to establish procedures for the assessment of pharmacovigilance cases to ensure accurate evaluation of adverse event reports and other safety information.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the assessment of case reports, including safety specialists, medical reviewers, and managers.

3) Responsibilities

The Case Assessment Team is responsible for evaluating pharmacovigilance cases. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preliminary Case Review

1. Receive the case report from the Case Intake Team.
2. Perform a preliminary review to ensure all necessary information is included in the case report.
3. Identify any missing information and request follow-up as needed.

4.2 Case Assessment Criteria

1. Evaluate the seriousness of the adverse event based on predefined criteria (e.g., hospitalization, life-threatening, death).
2. Determine the expectedness of the adverse event in relation to the product’s labeling or reference safety information.
3. Assess the causality of the adverse event by considering the temporal relationship, medical history, and other relevant factors.

4.3 Detailed Case Review

1. Conduct a thorough review of the case report, including all relevant medical and clinical information.
2. Evaluate the consistency of the reported event with known information about the product and similar cases.
3. Document the findings of the detailed review, including any uncertainties or limitations.

4.4 Medical Review

1. Involve a qualified medical reviewer to assess the clinical aspects of the case.
2. Ensure the medical reviewer documents their assessment and any medical conclusions.
3. Address any discrepancies or uncertainties in the case report through further investigation or expert consultation.

4.5 Final Assessment and Documentation

1. Summarize the overall assessment of the case, including seriousness, expectedness, and causality determinations.
2. Ensure all assessment details are accurately recorded in the pharmacovigilance database.
3. Prepare a final case assessment report for regulatory submission and internal review.

4.6 Quality Control

1. Conduct regular quality control checks on case assessments to ensure consistency and accuracy.
2. Address any issues or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.7 Documentation and Record Keeping

1. Maintain detailed records of all case assessments, including preliminary reviews, detailed reviews, and medical reviews.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all data corrections and updates made during the case assessment process.

4.8 Communication

1. Communicate case assessment procedures and updates to all relevant staff members.
2. Provide training on case assessment tools and methods to ensure consistency and accuracy.
3. Report any issues or challenges encountered during case assessment to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Case reports, assessment reports, follow-up logs, quality control reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VI.

8) SOP Version

Version 1.0