➰ A Newcomer's Guide to ICSR Case Processing Workflow

This blog provides valuable insights into:

Beginner’s guide to case processing
Case processing workflow with references
Workflow diagram

📢 Notification: While perusing this blog, we also provide a complimentary checklist to enhance your ICSR case processing. Feel free to access it while navigating through the content.

Table of Contents:

Introduction
Exploring the Essential Stages of Case Handling
The Stages of Case Creation: Flow chart included
ICSR Case Processing Workflow: Flow chart Included
Conclusion
FAQ

Introduction

Standard processes are commonly followed in the case processing of Individual Case Safety Reports (ICSRs), which is a widespread practice in the field. In this blog, we will explore an outline of the processes involved in ICSR processing.

📢 Recommendations: If you are new to ICSR, you can refer to our previous blogs where we discussed the Fundamentals of ICSR in pharmacovigilance and explore the dedicated category on our page titled ICSR Management.

As we all aware, ICSR forms the foundation of all activities in pharmacovigilance.

Crucial Phases in Case Handling

The subsequent sequence outlines the typical steps in the processing of ICSR along with the responsible teams:

Case intake: Safety data Book-in team (To learn more…)
Triage: Safety data Book-in team/ Medical review (To learn more…)
Book-in: Safety data Book-in team (To learn more…)
Data entry/ case processing: Case processor/ Date entry associate (To learn more…)
Quality review: Quality Reviewer (To learn more…)
Medical review: Medical Reviewer (To learn more…)
Routing/ Submission: Medical Reviewer/ Case processor/ Date entry associate (To learn more…)

For a deeper look into each process, check out our previous blogs in the highlighted list above, each dedicated to a specific topic.

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Case creation

Case creation is a comprehensive workflow involving a collective series of actions, including case intake, triage, and book-in. After successfully passing through these three stages, the case proceeds to the subsequent phase of coding events and relevant details.

In the context of case management, “case intake” refers to the initial step of permitting cases to enter your workflow. This particular task may be carried out by a dedicated team within your company if such a team exists.

For your easy understanding, please refer the following flowchart, which illustrates the entire process of case creation.

ICSR process workflow

After successfully creating the case through the aforementioned filtering process, the subsequent step involves initiating the coding of safety data in the corresponding Pharmacovigilance database.

We have dedicated sections for each topic. To delve deeper into each topic, simply click on the relevant links listed above.

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To enhance simplicity and facilitate easy comprehension, we have attached a flow chart that explains the outline of the case processing workflow.

Please find the file below, which provides a visual representation of the steps involved in the case processing workflow.

📢 Recommendation: Since you’re exploring the ICSR process flow, to learn deeper into its significance in pharmacovigilance. You might be curious about why ICSR holds greater importance in pharmacovigilance.

Conclusion

This blog serves as a comprehensive overview, showcasing the graph-view of the ICSR case processing journey. It consolidates and illustrates the entire process, drawing from the collective wisdom shared in our previous blog editions.

Hopefully, While this workflow aligns with common industry practices, if you have any suggestions for enhancing its effectiveness,

“Feel free to leave your thoughts as comments below.”

FAQ:

What is ICSR case processing?

ICSR stands for Individual Case Safety Reports, refers to the systematic handling and evaluation of safety reports related to individual cases of adverse events or reactions associated with pharmaceutical products, medical devices, or other healthcare interventions. Click here to know more.

What is ICSR case creation?

Case creation is a comprehensive workflow involving a collective series of actions, including case intake, triage, and book-in.

What are the important workflows of ICSR case processing?

1. Triage and Book-in
2. Complete data entry
3. Quality review
4. Medical review
5. Case routing

What is the entry level position in pharmacovigilance?

For most healthcare professionals (excluding physicians), the entry-level position in pharmacovigilance is typically a case processor. In some cases, physicians also start at the entry level as case processors.

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.