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