This blog features:
- Scenarios that require case nullification
- Scenarios that do not require case nullification
- Key takeaways
Table of Contents
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 key points and best practices to follow. This chapter serves as a focused reference to help ensure consistency and accuracy in the process.
As previously discussed, we won’t delve into the fundamentals of what case nullification is, why it’s essential, or how the process works.
Instead, this blog focuses specifically on the do’s and don’ts of case nullification, offering practical guidance to navigate common challenges and ensure proper handling.
/Why Awareness Matters?
In most scenarios, case processors are responsible for identifying duplicate cases and initiating the nullification process.
Yet, errors often occur due to uncertainty and confusion around which cases truly require nullification.
That’s why it’s crucial to have a clear understanding of which cases should and should not be nullified. Once a case is nullified—especially by mistake or oversight—it cannot be retrieved, which can impact data integrity and compliance.
While nullification decisions are not solely the case processor’s responsibility and should be thoroughly reviewed before action is taken, the initial judgment often starts with them. It’s a shared responsibility, and when mishandled, it can directly affect the overall quality of case management.
“Case nullification is not just the end of a report—it’s a decision that demands clarity, compliance, and conscience.”
The Do’s and Don’ts
The tables below are based on EMA guidelines and outline various example scenarios, along with the appropriate actions to be taken in each case.
Here are some common scenarios that do and do not qualify for case nullification:
Scenarios that Require Nullification
| Example | Scenario | Action |
|---|---|---|
| 1. | An individual case is identified as a duplicate of another previously submitted case. | One of the cases should be nullified, and the remaining valid case should be updated with any relevant information from the nullified case. |
| 2. | A wrong ‘Worldwide unique case identification number’ (ICH-E2B(R2)) was accidentally used and does not correspond to an existing case. | The case with the incorrect ‘Worldwide unique case identification number’ (ICH-E2B(R2) A.1.10) should be nullified. A new case should be created with the correct identification number. |
| 3. | Upon receiving additional information, it is confirmed that the patient did not receive the suspect drug, and the minimum reporting criteria for an ICSR are no longer met. | The case should be nullified. |
| 4. | Additional information confirms that the adverse reaction occurred before the suspect drug(s) was taken. | The case should be nullified. |
| 5. | Further information from the same reporter confirms that the reported adverse reaction(s) did not occur in the patient, and the minimum reporting criteria for an ICSR are no longer met. | The case should be nullified. |
| 6. | Additional information reveals that there was no valid patient for the individual case, and the minimum reporting criteria for an ICSR are no longer met. | If confirmation of the patient’s existence is impossible, the case should be nullified. |
Scenarios That Not Require Nullification
| Example | Scenario | Action |
|---|---|---|
| 1. | A wrong ‘Worldwide unique case identification number’ (ICH E2B(R2) A.1.10) was accidentally used, but the incorrect identification number referred to an existing case. | The report with the wrong ‘Worldwide unique case identification number’ should not be nullified. A follow-up report should be submitted to correct the information, and a new ICSR should be created with the correct identification number. |
| 2. | Additional information reveals that the patient did not receive the suspect drug, but received other suspect drugs, and the minimum reporting criteria for an ICSR are still met. | The case should not be nullified. |
| 3. | Further information confirms that the reported adverse reaction is no longer considered related to the suspect medicinal product(s). | The case should not be nullified. A follow-up report should be submitted within the appropriate time frame with the updated information. |
| 4. | The individual case is downgraded from serious to non-serious. | The case should not be nullified. A follow-up report should be submitted with the ‘Seriousness’ data element populated with ‘No’, without selecting a value for ‘Seriousness criteria’. The ‘Does this case fulfil the local criteria for an expedited report?’ field should remain populated with ‘Yes’. |
| 5. | The primary source country changes, which affects the ICH-E2B(R2) convention for creating the ‘Worldwide unique case identification number’. | The case should not be nullified. The ‘Sender’s (case) safety report unique identifier’ can be updated based on the new primary source country code, while the ‘Worldwide unique case identification number’ should remain unchanged. If the sender’s system cannot accommodate this, the original case should be nullified, and a new case with the updated country code should be created. The original case’s identification number should be reflected in the data elements ‘Other case identifiers in previous transmissions’. |
| 6. | The suspected medicinal product belongs to another marketing authorisation holder, such as a product with the same active substance but marketed under a different name. | The case should not be nullified. The initial sender should inform the other marketing authorisation holder and submit a follow-up report. The second holder should create a new case, specifying the reference case number and the initial sender’s name for grouping in the EudraVigilance database. |
| 7. | The suspected medicinal product does not belong to the marketing authorisation holder, and the report originates from a country where the holder has no authorisation for that product. | The case should not be nullified. The marketing authorisation holder should submit a follow-up report with the updated information within the appropriate time frame. |
| 8. | The case is mistakenly reported by marketing authorisation holder A, while marketing authorisation holder B is responsible for reporting the case. | The case should not be nullified. Marketing authorisation holder A should notify holder B that the case was already reported, and holder B should submit any additional information as a follow-up report with the same ‘Worldwide unique case identification number’. |
Key takeaways
Once a case is nullified, it cannot be restored or retained.
Exercise caution when nullifying cases—ensure thorough review before taking action.
All nullified cases are archived and remain accessible for audit purposes.
Nullification does not delete a case; it simply removes it from the active workflow.
What can we do to enhance your workflow efficiency?
“Are you looking to efficiently correct and streamline your workflow through duplicate identification, case merging, and nullification as part of a dedicated project?”
Don’t let your mind get overwhelmed—just block time on your calendar and book a call with us.
Conclusion
From the points above, you should now have a much clearer understanding of how to approach case nullification with more confidence. We’ve covered nearly all common scenarios where nullification applies.
This article may have highlighted aspects you hadn’t considered before.
Do you find this content helpful in your case processing workflow? Is there anything important we might have missed regarding nullification?
Feel free to share this with your friends and colleagues—it could be a valuable resource for them too!
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