This blog covers:
- The difference between significant and non-significant follow-ups.
- How to identify and manage these scenarios effectively.
- The importance of noticing them.
Table of Contents
Introduction
In pharmacovigilance case processing, the quality of submissions depends on addressing knowledge gaps in the subject matter.
Often, critical details are overlooked or disregarded, leading to inconsistent practices.
To ensure clarity in case processing, we consistently detailing every aspect of pharmacovigilance.
This content highlights the differences between significant and non-significant reports, what we unaware.
Definitions
The definitions below are drawn from experience and supported by references.
Understanding these concepts is critical to avoiding errors in regulatory submissions.
Significant Reports
In a simple note, significant reports should contain clinically relevant information that need regulatory notice.
When a report is initially received, the information may be incomplete. These reports must be followed up as necessary to get more details crucial for thorough scientific assessment.
Non-Significant Reports
Non-significant reports, in contrast, do not contain information with clinical significance or impact on medical evaluation.
Non-significant information does not need regulatory submission, even in follow-ups and case corrections. As they lack material significance
Examples include:
- Correcting typographical errors in narratives.
- Updating MedDRA coding without affecting the preferred term (PT).
- Amending the reporter’s details (e.g., changing from one HCP to another or from one consumer to another).
- Minor date changes that do not affect case evaluation.
✍️ Note: The distinction between significant and non-significant reports primarily holds on regulatory submissions.
“Significance lies not in the volume of details but in their impact on the bigger picture.”
Determine the Report: Significant or Non-Significant
The following points can help differentiate significant cases based on the source of the report:
- Initial Reports: All initial reports are considered significant.
- Clinical Importance: Reports with gaps in clinically significant information, received through follow-up.
- Case Classification Changes: Updates that alter the classification of a case during follow-up.
- Causality Amendments: Changes or updates to causality assessments.
- Patient Details: Updates to key patient demographics, such as date of birth (DOB) or initials.
- Drug Information: Key details about the drug, including its dosage.
- Significant Corrections: Any amendments that materially affect the case evaluation.
- ICSR Submissions: New medical or administrative information impacting the case, such as:
- A newly suspected adverse reaction.
- Addition of a new suspected drug.
- Medical interpretations impacting the case.
- Medical Evaluation: Amendments that significantly influence medical evaluation require ICSR resubmission.
- Severity Changes: Upgrades or downgrades in seriousness criteria.
- Study-Related Updates: Updates to study ID, title, or type.
- Outcome Changes: Modifications to patient outcomes.
- Action Taken: Any updates on actions taken regarding the drug or patient.
- Event Details: Changes to event descriptions, start/end dates, or recoding.
All significant reports should be submitted to the competent authorities. Medical judgment is essential in identifying significant new information. Ensure submissions as a follow-up ICSR.
✍️ Note: Changes such as updates to MedDRA codes/terms (e.g., from current to non-current due to a MedDRA version update) can generally be considered non-significant. If they do not impact the medical content of the case.
Importance of Marking Cases
Validating a Significant Case
When performing a follow-up, if significant information is identified, it is crucial to mark the case as significant.
Most databases provide designated checkboxes, to indicate whether a case is significant or non-significant. It is your responsibility to ensure the correct marking based on the report.
Significance of Accurate Marking
When you find the FU requires submission, the clock for follow-up report submission resets based on the date of latest receipt.
As many databases are automated, the system proceed for submission based on the marking:
- Unchecked cases may result in missed submissions.
- Checked cases will proceed for submission as per regulations.
Accurate marking ensures compliance with submission requirements and avoids regulatory oversights.
Key Takeaways
Definition of Significant Cases: All Significant reports involve the receipt of new, clinically relevant information.
Default Status: Initial cases are automatically marked as significant and require submission.
Changes to Existing Cases: Any significant updates to existing cases also necessitate submission.
Database Integration: Each database provides a designated section to mark the significance of new information received.
Submission Requirement: All significant cases requires submission, while non-significant cases do not.
Report Classification: New information, whether significant or non-significant, is treated as a follow-up report, not an amendment.
Significance Varies: Not all follow-up information is significant.
Conclusion
This guide provides a detailed differences of significant and non-significant reports. It aims to helping professionals understand the nuances of case processing.
It outlines key characteristics, responsibilities, and the importance of accurate marking to ensure the reports never missed.
Did we miss anything? Feel free to share your recommendations or suggest any additional points we could cover.
If you found this content helpful, share it with your friends and colleagues to spread awareness and improve case processing practices.
Bibliographic References:
‘1. Guideline on good pharmacovigilance practices (GVP) – Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)’ (no date). Visit Website
Leave a Reply