This blog covers:
- An overview of case corrections
- The importance of case corrections in pharmacovigilance
- Some examples of case corrections
Table of Contents
Introduction
This article aims to explain the concept of case corrections in pharmacovigilance case processing.
In real-world scenarios, errors and subsequent corrections are frequently encountered. These corrections may be either significant or non-significant in nature. This discussion explores the key nuances and essential details related to case corrections.
Case Corrections: An Overview
In pharmacovigilance, a case correction refers to the process of modifying, updating, or rectifying a previously submitted Individual Case Safety Report (ICSR) when new, missing, or incorrect information is identified after the initial submission.
Case corrections typically arise when errors or action items are identified by the Quality Assurance (QA) team or reported by the client. These corrections help ensure that safety data remains accurate, complete, and compliant with regulatory expectations.
Performing Case Corrections
Both significant and non-significant errors must be corrected as part of routine pharmacovigilance operations.
Case corrections are performed in accordance with the internal processes defined by each organization. Most companies follow their own Standard Operating Procedures (SOPs) and use approved templates and workflows to ensure consistency, traceability, and compliance during case correction activities.
One common requirement across all organizations is that the case must be properly unlocked if it is in a locked status before any correction is made. Once unlocked, corrections should be completed based on defined priority and regulatory timelines.
Importantly, case corrections should never be avoided. Every identified error—regardless of its significance—must be addressed promptly to maintain data integrity, regulatory compliance, and inspection readiness.
“Accuracy in every case isn’t just a standard—it’s a responsibility that safeguards patient safety.”
Why Case Corrections Are Important
Case corrections are critical for:
- Data accuracy & integrity
- Regulatory compliance
- Reliable signal detection
- Correct benefit–risk assessment
- Avoiding regulatory findings and audit observations
Incorrect or outdated safety data can lead to:
- Missed safety signals
- Delayed regulatory action
- Compliance violations
Some Common Case Corrections
The following are some of the most common errors identified during quality audits that require case correction:
- MedDRA coding errors
- Incorrect event assessment
- Errors in narrative writing
- Missing concomitant medications from the source data
- Incorrect categorization of patient history or medical details
- Drug coding errors, particularly for concomitant or treatment drugs
- Improper or incorrect causality assessment
- Missing seriousness criteria for one or more adverse events
Key takeaways
Case corrections are essential in pharmacovigilance to ensure the accuracy, completeness, and regulatory compliance of ICSRs.
Timely and accurate case corrections help maintain data integrity, inspection readiness, and patient safety.
Case corrections should be handled based on priority and regulatory timelines.
Both significant and non-significant errors must always be corrected—no error should be ignored.
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Conclusion
Case corrections play a vital role in maintaining the quality, reliability, and regulatory compliance of pharmacovigilance data.
As errors and updates are inevitable in real-world case processing, timely and accurate corrections ensure that safety information remains trustworthy and inspection-ready.
By following robust SOPs, prioritizing corrections appropriately, and maintaining proper documentation, organizations can strengthen their overall safety surveillance and protect patient safety.
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