Guidelines for Reviewing Pharmacovigilance Data Quality

1) Purpose

The purpose of this SOP is to establish standardized procedures for reviewing the quality of pharmacovigilance data to ensure accuracy, completeness, and consistency in safety reporting.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the data quality review process, including data entry operators, safety specialists, and managers.

3) Responsibilities

The Data Quality Review Team is responsible for conducting quality reviews of pharmacovigilance data. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Data Quality Review

1. Ensure access to all relevant data sources, including case reports, databases, and coding dictionaries.
2. Familiarize yourself with the data quality review guidelines and any recent updates.

4.2 Initial Data Quality Review

1. Select a representative sample of data entries for initial review.
2. Verify the accuracy and completeness of data entries by cross-referencing with source documents.
3. Identify any discrepancies, errors, or missing information.
4. Document any issues identified during the initial review.

4.3 Corrective Actions

1. Address any discrepancies or errors identified during the initial review by consulting with relevant personnel.
2. Update the data entries to correct any identified issues.
3. Document all corrective actions taken and the reasons for these changes.

4.4 Secondary Data Quality Review

1. Conduct a secondary review of the corrected data entries to ensure all issues have been resolved.
2. Verify the accuracy and completeness of the updated data entries.
3. Document the results of the secondary review.

4.5 Regular Data Quality Audits

1. Establish a schedule for regular data quality audits to ensure ongoing data integrity.
2. Conduct audits according to the established schedule, focusing on different aspects of data quality each time.
3. Document the results of each audit and any corrective actions taken.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all data quality review activities, including initial and secondary reviews, corrective actions, and audit results.
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 review and audit processes.

4.7 Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Data quality review logs, source documents, corrective action records, audit reports.

7) Reference, if any

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

8) SOP Version

Version 1.0