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.
-
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…
-
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…
-
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…
-
Regulatory Submissions in PV: Key Set of Rules
This blog covers the following topics: Introduction Today, almost every product we use is subject to regulatory oversight, not limited to medicines. Regulatory duties involve monitoring, market availability and ensuring its safety. When it comes to pharmaceutical products, the regulations are even more stringent due to their direct impact on public health. Each drug governed…
-
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…
-
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.
-
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…
-
CTCAE Explained: An Overview & Criteria
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,…
