Guidelines for Pharmacovigilance Data Entry and Verification

1) Purpose

The purpose of this SOP is to establish standardized procedures for accurate and timely data entry and verification in pharmacovigilance to ensure data quality and compliance with regulatory requirements.

2) Scope

This SOP applies to personnel involved in pharmacovigilance data entry, verification, and quality control within the Pharmacovigilance (PV) department.

3) Responsibilities

The Pharmacovigilance (PV) Data Manager is responsible for overseeing data entry and verification activities. PV Data Entry Operators and PV Quality Assurance personnel are responsible for executing tasks outlined in this SOP.

4) Procedure

4.1 Data Entry

1. Receive individual case safety reports (ICSRs) or adverse event data from various sources, including healthcare professionals, consumers, clinical trials, and spontaneous reports.
2. Enter data accurately and promptly into the pharmacovigilance database or case management system following standardized data entry procedures and data coding conventions.

4.2 Data Verification

1. Conduct initial data verification to ensure completeness and correctness of entered data, including patient demographics, medical history, concomitant medications, and adverse event details.
2. Verify data against source documents (e.g., case report forms, medical records) to confirm accuracy and consistency with reported information.

4.3 Quality Control Checks

1. Perform quality control checks on entered data to identify discrepancies, inconsistencies, or missing information that require resolution.
2. Resolve data discrepancies through collaboration with PV Data Entry Operators, Medical Reviewers, and relevant stakeholders to maintain data integrity.

4.4 Data Coding

1. Assign appropriate medical coding (e.g., Medical Dictionary for Regulatory Activities – MedDRA) to adverse events and medical terms following established coding guidelines and dictionaries.
2. Ensure consistency and accuracy in coding adverse events across pharmacovigilance databases and regulatory submissions.

4.5 Data Entry and Verification Documentation

1. Maintain comprehensive documentation of data entry and verification activities, including data entry logs, verification checklists, and audit trails.
2. Archive and manage data entry documentation in accordance with pharmacovigilance documentation management procedures and regulatory requirements.

4.6 Training and Competency

1. Provide training to PV Data Entry Operators on data entry procedures, data coding standards, and pharmacovigilance database usage.
2. Assess competency of PV personnel involved in data entry and verification through periodic evaluations and training assessments.

4.7 Continuous Improvement

1. Regularly review and update pharmacovigilance data entry and verification procedures based on feedback, regulatory changes, and quality assurance findings.
2. Implement process improvements to enhance data quality, streamline data entry workflows, and mitigate risks associated with data discrepancies.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICSR – Individual Case Safety Report, MedDRA – Medical Dictionary for Regulatory Activities

6) Documents, if any

Data entry logs, verification checklists, data coding guidelines, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.

8) SOP Version

Version 1.0