Guidelines for Collecting Pharmacovigilance Data

1) Purpose

The purpose of this SOP is to outline the standardized procedures for collecting pharmacovigilance data to ensure accurate, consistent, and timely data capture for safety monitoring and reporting.

2) Scope

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

3) Responsibilities

The Data Collection Team is responsible for gathering pharmacovigilance data from various sources. The Pharmacovigilance (PV) Manager oversees the process to ensure data integrity and compliance with regulatory requirements.

4) Procedure

4.1 Data Sources

1. Identify and document all relevant data sources, including clinical trials, spontaneous reports, literature, and safety databases.
2. Ensure access to these data sources is secured and maintained.

4.2 Data Collection Methods

1. Use standardized forms and electronic systems to collect data consistently.
2. Ensure all data fields are completed accurately and comprehensively.
3. Verify the accuracy and completeness of the collected data.

4.3 Data Entry

1. Enter collected data into the pharmacovigilance database promptly.
2. Perform quality checks to ensure data integrity and accuracy.
3. Address any discrepancies or missing information through follow-up.

4.4 Data Storage and Security

1. Store collected data securely to prevent unauthorized access or loss.
2. Implement data encryption and backup procedures to ensure data protection.
3. Maintain data confidentiality in accordance with privacy regulations.

4.5 Data Review and Validation

1. Regularly review collected data for accuracy and completeness.
2. Validate data entries through cross-referencing with source documents.
3. Update and correct any errors or omissions identified during the review process.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all data collection activities, including source documents and data entry logs.
2. Ensure all documentation is stored securely and is easily accessible for audits and inspections.
3. Keep a log of all data corrections and updates made during the review and validation process.

4.7 Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Data collection forms, source documents, data entry logs, validation reports.

7) Reference, if any

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

8) SOP Version

Version 1.0