Guidelines for Conducting Pharmacovigilance Aggregate Analysis

1) Purpose

The purpose of this SOP is to establish standardized procedures for conducting aggregate analysis of safety data to identify trends, patterns, and potential safety signals.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the analysis of aggregate safety data, including safety specialists, data analysts, and managers.

3) Responsibilities

The Analysis Team is responsible for performing the aggregate analysis. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Data Collection

1. Identify and collect relevant safety data from various sources, including individual case safety reports (ICSRs), clinical trial data, and literature reviews.
2. Ensure all data is accurate, complete, and up-to-date before beginning the analysis.

4.2 Data Preparation

1. Organize the collected data into a structured format suitable for analysis.
2. Clean the data by removing duplicates, correcting errors, and standardizing formats.
3. Ensure all relevant variables and data points are included in the dataset.

4.3 Conducting Aggregate Analysis

1. Apply statistical methods to analyze the aggregate safety data, identifying trends, patterns, and potential safety signals.
2. Use specialized software and tools for data analysis, such as SAS, R, or SPSS.
3. Conduct subgroup analyses to identify any specific populations at higher risk.
4. Document the methodology and results of the analysis in a detailed report.

4.4 Interpretation of Results

1. Interpret the findings from the aggregate analysis to determine the clinical significance and potential impact on the product’s safety profile.
2. Assess the need for further investigation or immediate action based on the results.
3. Document the interpretation and conclusions in the analysis report.

4.5 Review and Approval

1. Submit the aggregate analysis report to the PV Manager and other relevant stakeholders for review.
2. Incorporate any feedback or revisions from the review process into the final report.
3. Obtain formal approval of the final analysis report from the PV Manager or authorized signatory.

4.6 Communication of Findings

1. Communicate the findings of the aggregate analysis to relevant internal and external stakeholders.
2. Provide recommendations for any necessary actions, such as updates to the risk management plan or label changes.
3. Ensure timely communication of any urgent safety concerns to regulatory authorities and healthcare professionals.

4.7 Documentation and Record Keeping

1. Maintain detailed records of all data used in the aggregate analysis, including raw data, cleaned datasets, and analysis reports.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.8 Training and Communication

1. Communicate aggregate analysis procedures and updates to all relevant staff members.
2. Provide training on data analysis tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during the aggregate analysis process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance
ICSR – Individual Case Safety Report

6) Documents, if any

Case reports, clinical trial data, literature reviews, raw and cleaned datasets, analysis reports, quality control reports.

7) Reference, if any

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

8) SOP Version

Version 1.0