This Blog Features
- Practical processing of serious and non-serious cases
- Key points to consider when assessing seriousness and expedited reporting
- Practical considerations for handling cases accurately and compliantly
- Important principles every case processor should keep in mind during ICSR processing
Introduction
When processing an individual case safety report (ICSR), identifying whether the reported adverse event (AE) is serious or non-serious is one of the first and most important steps. However, SAE and non-SAE classification is not just a matter of selecting a field in the safety database. It can influence the way the entire case is processed, reviewed, and assessed for regulatory reporting.
The following are some of the important practical considerations for case processors.
1. Start by Identifying the AE and Assessing Seriousness
As a case processor, the first step is to identify the reported adverse event and determine whether it meets any of the applicable seriousness criteria.
The source and references information should be reviewed carefully rather than relying only on the terminology used by the reporter.
2. An Event May Be Critical for One Drug but Not for Another
An event may appear critical based on general assumptions, but its significance can differ depending on the specific product, indication, and applicable criteria. An event that appears serious or critical at first assessment may not meet the relevant criteria for a particular drug.
Therefore, always carefully review the product protocol, reference safety information, and other applicable product-specific reference documents before making the final assessment.
3. Case Criterion
One of the most important aspects of case processing is determining whether the case contains only non-serious events or whether at least one event meets a seriousness criterion.
A case may contain multiple adverse events, and each event should be assessed appropriately. The presence of even one event that meets a seriousness criterion can have implications for the overall case processing and reporting assessment.
4. A Serious Event Can Make the Case a Serious Case
When an event meets an applicable seriousness criterion, the case is generally handled as a serious case for the relevant processing and reporting assessment.
However, this does not mean that every event reported in the case should automatically be classified as serious. Each event should continue to be assessed based on the information available.
5. Seriousness and Expedited Reporting Are Not the Same Thing
A Non-serious event does not necessarily mean that every aspect of the case is not-expedited, but all the serious is expedited.
Seriousness and expedited reporting are two different assessments.
The processor should therefore evaluate the applicable reporting criteria rather than assuming that:
Serious = Expedited
Non-serious = Does not mean that all are non-expedited
The applicable regulatory requirements should always be considered.
6. Expedited Cases Must Meet the Applicable Regulatory Timeline
When a case meets the applicable criteria for expedited reporting, it must reach the relevant regulatory authority within the prescribed reporting timeline.
The 15-calendar-day timeline is commonly used for certain expedited safety reports, but it should not be treated as a universal rule for every jurisdiction and every report type. The applicable regulatory requirement should always be confirmed.
Therefore, case queues and timelines should be actively monitored to prevent avoidable delays
7. Every Expedited Case Must Be Submitted Within the Applicable Timeline
Once a case has been determined to require expedited reporting, the processing workflow should ensure that it progresses through all required steps and reaches the relevant regulatory authority within the applicable regulatory timeline.
The focus should not only be on completing the case but also on completing it within the required timeframe.
8. Serious Cases Commonly Go Through Quality Review Before Submission
Many organizations follow a structured workflow in which serious cases undergo quality control before they are routed for regulatory submission.
A typical workflow may be:
Case Receipt → Processing → Medical/Quality Review → Regulatory Submission
The exact workflow may differ between organizations, but quality review provides an important opportunity to identify errors before submission.
9. Do Not Unnecessarily Upgrade or Downgrade an Adverse Event
An adverse event should not be upgraded or downgraded without sufficient evidence.
The processor should not upgrade an event simply because another event in the same case is serious. Similarly, an event should not be downgraded simply to avoid additional processing or regulatory reporting.
Any change in classification should be supported by the available source information and the applicable criteria.
10. The Timing of Any Classification Change Is Important
If an existing event is subsequently upgraded or downgraded, the processor should consider when the new information was received and when the classification changed.
This is important because a change in seriousness or other case characteristics may affect the regulatory assessment and reporting timeline.
Therefore, the relevant dates should be documented and the case should be reassessed whenever new information changes the classification.
11. A Change in Seriousness Must Be Supported by Valid Criteria
An existing event should only be upgraded or downgraded when the newly available information provides a valid basis for making that change.
For example, if follow-up information indicates that an event resulted in hospitalization or meets another applicable seriousness criterion, the case should be reassessed based on that new information.
The key principle is:
Seriousness should follow the evidence, not the desired reporting outcome.
12. Seriousness Changes Require Regulatory Submission
Any change in seriousness classification—whether an upgrade or downgrade—should be carefully assessed, the appropriate regulatory submission or follow-up report should be made in accordance with the applicable regulatory timeline. And both should be expedited. For example upgraded and downgraded.
Conclusion
SAE and non-SAE assessment is one of the fundamental decisions in ICSR processing and should never be treated as merely an isolated database field.
A robust case-processing approach requires the processor to remain aligned with applicable regulatory requirements at every stage. Ultimately, the responsibility is to ensure that each case is processed accurately and compliantly.
The objective is not to make a case serious or non-serious. The objective is to classify and process the case accurately based on the available evidence, applicable criteria, and regulatory requirements.
