Guidelines for Pharmacovigilance Database Query Management
1) Purpose
The purpose of this SOP is to establish procedures for managing queries in the pharmacovigilance database to ensure accurate and timely data retrieval for safety assessment and regulatory reporting.
2) Scope
This SOP applies to personnel responsible for querying pharmacovigilance databases, including pharmacovigilance data managers, safety scientists, and database administrators.
3) Responsibilities
The Pharmacovigilance Data Manager is responsible for overseeing database query operations. Safety scientists and pharmacovigilance officers utilize query results for safety assessment and regulatory reporting.
4) Procedure
4.1 Query Formulation and Submission
- Receive query requests from pharmacovigilance stakeholders, including safety assessors, medical reviewers, and regulatory affairs personnel.
- Formulate database queries based on predefined criteria, such as adverse event type, patient demographics, and product-specific parameters.
4.2 Query Execution and Data Retrieval
- Execute formulated queries in the pharmacovigilance database management system (DBMS) to retrieve relevant safety data and adverse event reports.
- Ensure accuracy and completeness of query results by validating data integrity and adherence to query specifications.
4.3 Data Review and Analysis
- Review retrieved data sets to identify relevant safety signals, adverse event trends, and patient population characteristics.
- Analyze query results for completeness of adverse event information, consistency with source documents, and compliance with regulatory reporting requirements.
4.4 Query Resolution and Follow-up
- Resolve discrepancies or data anomalies identified during query execution through data reconciliation and verification processes.
- Follow up with pharmacovigilance stakeholders to address query-related inquiries, provide additional data clarification, or revise query parameters as necessary.
4.5 Documentation and Reporting
- Document query formulation, execution details, and query results in query management logs or database query history.
- Generate query summary reports for safety assessment meetings, regulatory submissions, and internal quality assurance reviews.
4.6 Continuous Improvement
- Conduct periodic reviews of database query processes to identify opportunities for process optimization, efficiency enhancements, and training needs.
- Implement updates to query management procedures based on feedback, lessons learned, and evolving pharmacovigilance database technologies.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, DBMS – Database Management System
6) Documents, if any
Query management logs, query execution reports, data reconciliation summaries.
7) Reference, if any
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Pharmacovigilance Data Management.
8) SOP Version
Version 1.0
