Guidelines for Entering Pharmacovigilance Data

1) Purpose

The purpose of this SOP is to establish standardized procedures for entering pharmacovigilance data to ensure accuracy, consistency, and completeness in the pharmacovigilance database.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in data entry activities, including data entry operators, safety specialists, and managers.

3) Responsibilities

The Data Entry Team is responsible for accurately entering adverse event data into the pharmacovigilance database. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Data Entry

1. Receive case reports and relevant documentation from the Case Intake Team.
2. Review the case reports to ensure all necessary information is available for data entry.
3. Organize and prioritize cases based on the seriousness and urgency of the adverse events.

4.2 Data Entry Process

1. Access the pharmacovigilance database and log in using authorized credentials.
2. Open a new case entry form or update an existing case as required.
3. Enter the patient information, including age, gender, and relevant medical history.
4. Document the adverse event details, including onset date, symptoms, and severity.
5. Record any concomitant medications and their respective dosages and durations.
6. Input the results of any relevant tests or investigations related to the adverse event.
7. Ensure the causality assessment and seriousness classification are accurately recorded.
8. Review the entered data for accuracy and completeness before saving the entry.

4.3 Quality Control

1. Conduct regular quality control checks on data entries to ensure accuracy and consistency.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.4 Data Correction and Update

1. Identify and correct any errors or missing information in the entered data as needed.
2. Update the case entry with new information received from follow-up activities or additional reports.
3. Document all data corrections and updates in the pharmacovigilance database.

4.5 Documentation and Record Keeping

1. Maintain detailed records of all data entries, including initial entries, corrections, and updates.
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 data entry process.

4.6 Training and Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Case reports, data entry logs, quality control reports, data correction logs.

7) Reference, if any

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

8) SOP Version

Version 1.0