This blog covers:
- The process of case merging
- Essential requirements for merging cases
- Key considerations and important points
Table of Contents
Introduction
Have you ever wondered how to merge cases effectively without compromising important information?
In this comprehensive blog, we’ll guide you through the essential checklist to follow during the case merging process — from the initial steps to the key indicators you need to monitor along the way.
Whether you’re just starting out in case management or aiming to streamline your current workflow, this guide will help you merge cases with confidence and precision.
“Don’t fear complexity—master the basics during training, and confidence will follow in the real work.”
Key points in merging of cases
Duplicate cases are typically managed through a structured process of merging two or more cases into a single master case. This ensures consistency, traceability, and data integrity.
The following are key points and best practices to consider during the case merging process:
- Start with Identify and Confirm Duplicates
- Perform case clustering
- Choosing a right master case
- Merging decisions and choosing the master case, especially those involving specificity or clinical significance, should always be guided by sound medical judgment.
- Regarding the adverse reactions, one can choose to merge all reported reactions as presented in the duplicated cases in the master case.
- Merge All Relevant Information: All details from the duplicate cases—including sources, adverse reactions, narratives, and attachments—should be merged into the master case.
- Ensure Inclusion of All Case Reference Numbers: The master case must include all case reference numbers from the subordinate duplicate cases to maintain traceability.
- Amend Receipt Dates about the case merged for identification and keep significant
- The master case should retain its original classification unless there’s a justified reason to change it.
- Reclassify Duplicate Cases: Mark all subordinate duplicate cases clearly with the classification “Duplicate.”
- In order for NCAs to be able to identify which duplicated ICSRs have now been merged into the new Master ICSR the ICH E2B(R3) section Other Case Identifiers in Previous Transmissions will be populated with the worldwide case IDs of the duplicated cases. This section will be repeated for each duplicated ICSR that has been merged under the Master case.
- Once merging performed, never miss to links between the master case and all merged duplicates within the database or safety system.
- Regardless of the approach chosen, the master case should always contain all case reference numbers from all subordinate duplicate cases, such that they can be easily traced.
- In the event that ICSRs are incorrectly identified as duplicated cases and a Master case was created in error the EudraVigilance system will generate a Master nullification.
- Merging of cases require re-submission along with duplicates
- The master case should then be used for all subsequent pharmacovigilance activities, such as expedited and periodic reporting.
- Case reference numbers previously assigned to cases that subsequently merged with a master case should not be reused.
- Mention in the comment section about duplicates identified and merged
Key Takeaways
Assigning the correct case classification is a critical step in the merging process.
Ensure no information is lost when transferring data into the master case.
Duplicates marked for nullification cannot be restored—proceed with caution.
All merged and duplicate cases must be re-submitted with the updated case receipt date.
Always mention the details of merged duplicates in the narrative comment section.
Maintain proper linkage between the master and all duplicate cases for easy tracking and review.
How can we assist you?
Your workflow is detecting a high number of duplicate cases.
We manage the identification and merging of duplicates as a dedicated project—because preventing your workflow from getting clogged with duplicate cases is essential.
Yes, we do this so you don’t have to.
Conclusion
This write-up outlines the most essential steps and considerations involved in the merging of duplicate cases. By keeping these key points in mind, you can avoid common errors and ensure accurate, compliant, and effective case management.
Do you think we’ve missed something important?
We welcome your feedback—please feel free to share your insights or point out anything we’ve overlooked.
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