Guidelines for Entering Pharmacovigilance Data

1) Purpose

The purpose of this SOP is to establish the procedures for accurately and efficiently entering pharmacovigilance data into the database to ensure data integrity and facilitate timely safety monitoring and reporting.

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 entering pharmacovigilance data into the designated database. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal policies.

4) Procedure

4.1 Data Entry Preparation

1. Ensure that all source documents are complete and available before data entry begins.
2. Review the source documents to understand the information that needs to be entered.

4.2 Data Entry Process

1. Log into the pharmacovigilance database using secure credentials.
2. Select the appropriate data entry form or module based on the type of data being entered.
3. Enter data accurately and completely into the designated fields.
4. Use standardized coding systems (e.g., MedDRA) where applicable.
5. Save the data entry at regular intervals to prevent data loss.

4.3 Data Verification

1. Perform initial verification of entered data by cross-checking with the source documents.
2. Identify and correct any discrepancies or errors found during verification.
3. Document any changes made during the verification process.

4.4 Quality Control Checks

1. Conduct