Guidelines for Pharmacovigilance Safety Database Lock Procedures

1) Purpose

The purpose of this SOP is to establish procedures for locking the pharmacovigilance safety database at predefined intervals to ensure data integrity and regulatory compliance.

2) Scope

This SOP applies to personnel responsible for pharmacovigilance database management, including database administrators and pharmacovigilance managers.

3) Responsibilities

The Pharmacovigilance Database Administrator is responsible for executing database lock procedures. Pharmacovigilance Managers oversee the process to ensure adherence to timelines and quality standards.

4) Procedure

4.1 Database Lock Preparation

1. Review and finalize all incoming adverse event reports and updates in the pharmacovigilance safety database.
2. Verify completeness and accuracy of data entries, including case forms, coding, and narratives.

4.2 Data Quality Review

1. Conduct comprehensive data quality review to identify discrepancies, inconsistencies, or missing information.
2. Resolve discrepancies through reconciliation processes with source documents or follow-up queries to data providers.

4.3 Query Resolution

1. Address and resolve outstanding data queries, including discrepancies in case information, coding issues, and missing data fields.
2. Document resolution of queries and adjustments made to ensure data accuracy and completeness.

4.4 Database Freeze

1. Initiate database freeze process to prevent further data entry or modification during database lock procedures.
2. Implement measures to secure and maintain data integrity throughout the database lock period.

4.5 Lock Documentation

1. Prepare documentation to support database lock procedures, including lock logs, freeze date/time stamps, and data reconciliation reports.
2. Archive documentation in accordance with pharmacovigilance archiving procedures and regulatory requirements.

4.6 Quality Assurance Review

1. Subject database lock activities to quality assurance review to ensure compliance with SOPs, data integrity standards, and regulatory requirements.
2. Address findings and recommendations from quality assurance assessments to improve database lock processes and documentation practices.

4.7 Database Unlock Procedures

1. Establish procedures for database unlock following completion of data review, reconciliation, and quality assurance checks.
2. Coordinate with relevant stakeholders to authorize database unlock and resume data entry and processing activities.

4.8 Training and Competency

1. Provide training to pharmacovigilance staff involved in database lock procedures on SOP requirements, data integrity principles, and database management best practices.
2. Assess competency of database administrators through regular training evaluations and proficiency assessments.

4.9 Continuous Improvement

1. Conduct periodic reviews of database lock procedures to identify opportunities for process improvements, efficiency gains, and enhanced data management practices.
2. Implement corrective actions and updates to SOPs based on lessons learned, regulatory updates, and quality assurance feedback.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, FDA – Food and Drug Administration, EMA – European Medicines Agency

6) Documents, if any

Database lock logs, data reconciliation reports, training records.

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 – Computerized Systems Used in Clinical Investigations.

8) SOP Version

Version 1.0