Guidelines for Conducting Pharmacovigilance Literature Screening

1) Purpose

The purpose of this SOP is to establish standardized procedures for conducting literature screening to identify relevant safety information on medicinal products.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the literature screening process, including safety specialists, medical writers, and managers.

3) Responsibilities

The Literature Screening Team is responsible for performing literature searches and screening relevant articles. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Literature Screening

1. Identify the therapeutic areas and products for which literature screening is required.
2. Define the search criteria, including keywords, databases, and timeframes.
3. Document the search strategy in a literature screening plan.

4.2 Conducting the Literature Search

1. Perform literature searches using relevant databases (e.g., PubMed, Embase, Google Scholar).
2. Use predefined keywords and filters to retrieve relevant articles.
3. Save and document the search results, including the search date, databases used, and total number of articles retrieved.

4.3 Screening of Retrieved Articles

1. Review the titles and abstracts of the retrieved articles to determine their relevance to pharmacovigilance.
2. Include articles that contain safety information on the medicinal products of interest.
3. Exclude articles that do not meet the relevance criteria, documenting the reasons for exclusion.

4.4 Detailed Review of Relevant Articles

1. Perform a detailed review of the full text of the selected relevant articles.
2. Extract relevant safety information, including adverse events, risk factors, and benefit-risk assessments.
3. Summarize the findings and document them in a literature review report.

4.5 Documentation and Record Keeping

1. Maintain detailed records of all literature searches, including search strategies, results, and review notes.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.6 Quality Control

1. Conduct regular quality control checks on the literature screening process to ensure accuracy and consistency.
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 Training and Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Search strategies, search results, review notes, literature review reports.

7) Reference, if any

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

8) SOP Version

Version 1.0