Tag: All about ICSR processing
Within this tag, you will discover a complete repository of information pertaining to ICSR (Individual Case Safety Report) cases, presented systematically from top to bottom at each level.
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The Dos and Don’ts of Nullifying a Case
This blog features: Introduction Many pharmacovigilance professionals experience a range of uncertainties when it comes to the process of case nullification. One common scenario is identifying a duplicate case but not knowing which one should be nullified and which should be retained. To address this confusion, this guide provides clear direction on case nullification, highlighting…
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Case Merging: Critical Points You Never Miss
This blog covers: Introduction Have you ever wondered how to merge cases effectively without compromising important information? In this comprehensive blog, we’ll guide you through the essential checklist to follow during the case merging process — from the initial steps to the key indicators you need to monitor along the way. Whether you’re just starting…
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Causality: Known by Three Distinct Names
This blog covers: Introduction Causality is a well-known concept, and in pharmacovigilance, its assessment is fundamental—case processing simply cannot exist without it. However, within the pharmacovigilance domain, causality is often referred to using three distinct terms. If you’re experienced in the field, you’ve likely come across them, but for beginners, these variations might be unfamiliar.…
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Elements of the Four Valid ICSR Criteria
This Blog Features: Introduction Understanding the valid criteria for an Individual Case Safety Report (ICSR) is essential, yet many associates may be unaware of these key elements. As a result, invalid cases are sometimes processed due to a lack of clear definitions, leading to unnecessary nullifications. We have previously discussed the criteria for distinguishing a…
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Case Nullification: An Overview
This blog covers the following topics: Introduction Nullification occurs when a process is misleading or when a section fails to align with the required standards, rendering it invalid. In the context of pharmacovigilance, case nullification is commonly referred to as case deactivation. In this piece, we will explore the scenarios that necessitate case nullification as…
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Fundamentals of ICSR in pharmacovigilance
This blog is to explain about the fundamentals of Individual Case Safety Reports (ICSRs) and present them in an easily understandable manner. In this article, we provide dedicated definitions of key ICSR terms, ensuring clarity and comprehension with references.
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Treatment Received in ICSR: A Scenario
This blog features: Introduction As we know, every condition in our body requires treatment for proper healing. However, it’s important to remember that all medications can cause side effects. In the context of pharmacovigilance, defining treatment received is by the primary understanding from the source. Every drug has the potential to produce some kind of…
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Disease Progression: A Special Case of Adverse Events
This article explores the concept of disease progression in pharmacovigilance, highlighting its distinction from other adverse events like Loss of Efficacy (LOE). It explains how disease progression reports can be handled.
