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