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 to ensure accuracy and consistency.
2. Randomly select a sample of coded data for detailed review by a second team member.
3. Address any issues or errors identified during quality control checks.

4.5 Data Security and Confidentiality

1. Ensure all coded data is entered in a secure environment to prevent unauthorized access.
2. Maintain the confidentiality of all coded data in accordance with privacy regulations.
3. Implement data encryption and access control measures to protect data integrity.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all data coding activities, including source documents and verification logs.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all coding corrections and updates made during the verification and quality control processes.

4.7 Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance
MedDRA – Medical Dictionary for Regulatory Activities
WHO-ART – World Health Organization Adverse Reaction Terminology

6) Documents, if any

Source documents, coding dictionaries, verification logs, quality control reports.

7) Reference, if any

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

8) SOP Version

Version 1.0