SOP for Pharmacovigilance Medical Dictionary for Regulatory Activities (MedDRA) Coding

Guidelines for Pharmacovigilance MedDRA Coding

1) Purpose

The purpose of this SOP is to establish standardized procedures for the coding of adverse events and medical conditions using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in pharmacovigilance.

2) Scope

This SOP applies to personnel responsible for MedDRA coding in pharmacovigilance, including pharmacovigilance officers, safety scientists, and medical coding specialists.

3) Responsibilities

The Pharmacovigilance MedDRA Coder is responsible for accurately assigning MedDRA codes to adverse events and medical conditions reported in pharmacovigilance databases. Safety scientists and medical reviewers utilize coded data for safety assessment and regulatory reporting.

4) Procedure

4.1 Adverse Event Identification

Receive adverse event reports from pharmacovigilance stakeholders, clinical trials, spontaneous reports, and post-marketing surveillance.
Review adverse event descriptions and medical narratives to identify relevant medical terms and symptoms requiring MedDRA coding.

4.2 MedDRA Coding Process

Access MedDRA dictionaries and coding tools to select appropriate MedDRA terms based on the reported adverse event description.
Assign MedDRA preferred terms (PTs), high-level terms (HLTs), and/or system organ class (SOC) codes to accurately represent the adverse event or medical condition.

4.3 Coding Accuracy and Consistency

Ensure consistency and accuracy in MedDRA coding by following standardized coding conventions and guidelines.
Verify MedDRA codes against coding guidelines, conventions, and regulatory requirements

to maintain data quality and integrity.

4.4 Quality Assurance Checks

Perform quality assurance checks on coded data to validate accuracy, completeness, and adherence to MedDRA coding standards.
Document coding discrepancies or queries and collaborate with pharmacovigilance stakeholders to resolve coding issues.

4.5 Documentation and Reporting

Document MedDRA coding details, including assigned codes, coding rationale, and coding guidelines used for reference.
Generate MedDRA coding reports for adverse event data sets, regulatory submissions, and safety signal assessments.

4.6 Continuous Training and Improvement

Participate in ongoing training sessions and updates on MedDRA terminology, coding updates, and best practices in pharmacovigilance coding.
Implement feedback and lessons learned from coding audits, regulatory inspections, and internal quality assessments to improve coding efficiency and accuracy.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, MedDRA – Medical Dictionary for Regulatory Activities, PT – Preferred Term, HLT – High-Level Term, SOC – System Organ Class

6) Documents, if any

MedDRA coding guidelines, coding rationale templates, coding query logs, coding quality assurance reports.

7) Reference, if any

MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization, ICH E2E – Pharmacovigilance Planning.

8) SOP Version

Version 1.0