Guidelines for Generating Pharmacovigilance Line Listings

1) Purpose

The purpose of this SOP is to establish standardized procedures for generating line listings of adverse event (AE) data for regulatory reporting and internal analysis.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the creation and review of line listings, including safety specialists, data analysts, and managers.

3) Responsibilities

The Line Listing Team is responsible for the generation and validation of line listings. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Line Listing Generation

1. Identify the regulatory requirements and internal needs for line listings.
2. Gather all relevant data from the pharmacovigilance database, including individual case safety reports (ICSRs) and aggregate data.
3. Ensure all data is accurate, complete, and up-to-date before generating the line listing.

4.2 Data Extraction

1. Access the pharmacovigilance database to extract the necessary data for the line listing.
2. Ensure that the data extraction process captures all relevant variables and data points.
3. Document the data extraction process, including any queries or filters applied.

4.3 Generation of the Line Listing

1. Use specialized software tools to generate the line listing, ensuring proper formatting and organization of the data.
2. Include key data elements such as case identification number, patient demographics, event details, and outcome.
3. Ensure the line listing is clear, comprehensive, and compliant with regulatory guidelines.

4.4 Review and Validation

1. Submit the generated line listing to the PV Manager and other relevant stakeholders for review.
2. Conduct a thorough review to ensure the accuracy and completeness of the line listing.
3. Address any discrepancies or errors identified during the review process promptly.
4. Validate the final line listing to confirm it meets all regulatory and internal requirements.

4.5 Submission of the Line Listing

1. Submit the validated line listing to the relevant regulatory authorities within the required timeframe.
2. Use the appropriate submission method (e.g., electronic submission, postal mail) as specified by the regulatory authority.
3. Confirm receipt of the line listing by the regulatory authority and document the submission details.

4.6 Quality Control

1. Conduct regular quality control checks on line listings to ensure accuracy and compliance with regulatory requirements.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.7 Documentation and Record Keeping

1. Maintain detailed records of all line listings generated, including initial drafts, revisions, and final submissions.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all line listings submitted and their corresponding regulatory timelines.

4.8 Training and Communication

1. Communicate line listing generation procedures and updates to all relevant staff members.
2. Provide training on data extraction and line listing tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during the line listing generation process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance
ICSR – Individual Case Safety Report
AE – Adverse Event

6) Documents, if any

Case reports, data extraction logs, draft and final line listings, quality control reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VII.

8) SOP Version

Version 1.0