This blog covers the following topics:
- What is Case Nullification?
- The Principles and Process of Case Nullification
- Key takeaways
Table of Contents
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 a process.
Case Nullification: An Overview
Case nullification, also known as case deactivation, is the process of deactivating a case, not deleting it from the system.
The term “nullification” implies setting something to zero, as “null” means zero. Essentially, it refers to changing the case status to zero.
A nullified case is one that should no longer be considered for scientific evaluation. The process involves a notification from the sender to the receiver indicating that the case is no longer valid.
However, the case must be retained in the sender’s pharmacovigilance database for auditing purposes.
According to ICH-E2B(R2), the nullification of individual cases is used to indicate that a previously transmitted report should be considered completely void (nullified).
Example:
Case nullification is necessary when a case is found to be erroneous or when duplicate reports are identified. In such situations, it is important to use the same case report numbers that were previously submitted in the data elements ‘Sender’s (case) safety report unique identifier’ (ICH-E2B(R2)) and ‘Worldwide unique case identification number’ (ICH-E2B(R2)).
Nullifying a case is not the end, but a chance to reset, re-evaluate, and pursue justice with clarity and purpose.
General Principles in Case Nullification
- The value in the data element ‘Report nullification’ (ICH-E2B(R2)) should be set to ‘Yes,’ and the reason for nullification should be provided in the data element ‘Reason for nullification.’ The explanation should be clear and concise, outlining why the case is no longer considered a valid report.
- For example, reasons such as “the report no longer meets the reporting criteria” or “report sent previously in error” are insufficiently detailed.
- Only the sending organization can nullify an individual case.
- Once an individual case is nullified, it cannot be reactivated.
- If it becomes necessary to resubmit a case that has been previously nullified, a new ‘Sender’s (case) safety report unique identifier’ and ‘Worldwide unique case identification number’ must be assigned.
- Individual versions (e.g., follow-up reports) of a case cannot be nullified—only the entire individual case to which they refer can be nullified.
- The nullification process involves a notification from the sender to the receiver indicating the case is no longer valid. However, the case must be retained in the sender’s pharmacovigilance database for auditing purposes.
Once the case is confirmed for nullification, a clear justification should be provided. Some companies may require a specific form to be filled out with the necessary details before submitting the nullification.
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Key Takeaways
Case nullification involves deactivation, not complete deletion.
Nullified cases are archived for future auditing purposes.
Only the sender of the case can initiate the nullification process for the case processing unit.
Once nullified, cases cannot be retrieved, reactivated, or reopened for further processing.
Nullification should only occur once all relevant information has been merged with the master case.
A nullified case should no longer be considered for scientific evaluation.
Wrap Up
This comprehensive write-up has provided you with a clear understanding of what case nullification is, how it works, and the scenarios that qualify or do not qualify for nullification.
Whether you’re a beginner or a more experienced associate, this content offers valuable insights into the case nullification process.
If you believe we’ve missed any important details or if there’s something you’d like us to explore further in future content, feel free to share your thoughts with us. We appreciate your feedback and recommendations.
Don’t forget to share this informative content with your colleagues or friends. Thanks for sharing!
References:
- ‘Guidelines on Good Pharmacovigilance Practices: Module VI – Management and reporting of adverse reactions to medicinal products’ (no date).
- “EU Individual Case Safety Report (ICSR)1 Implementation Guide.” EMA Official, n.d.
- FDA – E2B(R3).
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