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
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
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
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
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
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…
-
Action Taken and Outcome: Explained
This comprehensive blog will guide you through the fundamentals of “action taken” in case files and its impact on patient outcomes, highlighting their interrelation.
-
🗝️ 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.
-
🖇 Case Merging: Key Concepts and Criteria Explained
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…