Guidelines for Coding Pharmacovigilance Data

1) Purpose

The purpose of this SOP is to define the procedures for coding pharmacovigilance data to ensure standardized and accurate classification of safety information.

2) Scope

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

3) Responsibilities

The Data Coding Team is responsible for coding pharmacovigilance data. The Pharmacovigilance (PV) Manager oversees the process to ensure consistency and compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Data Coding Preparation

1. Ensure access to the latest versions of coding dictionaries and guidelines, such as MedDRA and WHO-ART.
2. Familiarize yourself with the coding guidelines and any recent updates.

4.2 Data Coding Process

1. Review the source documents and identify the terms to be coded.
2. Search for the appropriate codes in the coding dictionaries using standardized methods.
3. Select the most accurate and specific code for each term.
4. Enter the selected codes into the pharmacovigilance database, ensuring correct mapping to the respective data fields.

4.3 Data Verification

1. Perform initial verification of coded data by cross-checking with the source documents and coding dictionaries.
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 regular quality control checks on coded data