Category: ICSR Management

Greetings and welcome to our ICSR community! Here, we share valuable insights on the nuances of ICSR case processing, no matter how small, to help you process cases effectively. We believe in sharing knowledge and information that we have to help our community grow.





  • CTCAE Explained: An Overview & Criteria

    CTCAE Explained: An Overview & Criteria

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    This blog covers the following topics: Introduction Many healthcare professionals (HCPs) and those involved in pharmacovigilance may not be fully aware of CTCAE or how it is derived. In this article, we provide an overview of CTCAE, explaining each grade and how to interpret them. You might wonder why some cases are reported as non-serious,…

  • Master Cases in ICSR Management

    Master Cases in ICSR Management

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    In this blog, we take a deep dive into ICSR management, focusing on an important aspect: managing duplicates. This time, we explore the process of selecting a master case for merging duplicate cases effectively.

  • Serious Adverse Events: Criteria and Guidelines

    Serious Adverse Events: Criteria and Guidelines

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    This blog explores how to effectively handle significant events, focusing on what qualifies as a “serious” event and the process of upgrading or downgrading events as they unfold. Understanding the severity of an event allows for a more adaptive and responsive approach to event management.

  • Categorizing Reports: Significant vs Non-Significant

    Categorizing Reports: Significant vs Non-Significant

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    From this comprehensive blog, you will gain insights into the nuances of handling significant vs non-significant reports in ICSR case processing.

  • Coding with Clarity:Adverse Events & Indications & Current Conditions

    Coding with Clarity:Adverse Events & Indications & Current Conditions

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    This blog features: Introduction Confusions and uncertainty are common in every profession. Gaining clarity in subject matter is the only choice to excelling in the field. Similarly, many healthcare professionals (HCPs) in pharmacovigilance still face challenges. Particularly in capturing different types of medical conditions. This often stems from a insufficient updates within the them. In…

  • 🖇 Case Merging: Key Concepts and Criteria Explained

    🖇 Case Merging: Key Concepts and Criteria Explained

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    This blog covers: Introduction In this comprehensive blog, we will delve into the nuances and criteria that determine when cases need merging. In one of our previous article, we explored what is a duplicated case and why merging is necessary. Here, we take a deeper look at the key factors that drive the need for…

  • 👥 Mastering Duplicate Detection: Your Ultimate Guide

    👥 Mastering Duplicate Detection: Your Ultimate Guide

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    In this detailed blog, we delve into the detection of duplicates in pharmacovigilance case processing, incorporating statistical insights throughout our exploration. Join us on our journey as we share our findings and insights.

  • ➕ Understanding Duplicates in Pharmacovigilance

    ➕ Understanding Duplicates in Pharmacovigilance

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    This blog covers: Introduction Duplicate reports are a regular challenge in pharmacovigilance case processing, encountered by professionals. This blog aims to gain a understanding of duplicates and their global impact on pharmacovigilance datasets. We’ll discuss methods for: What Are Duplicates? Duplicates refer to where a case file exists in many versions, that contains similar information…

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