This blog covers:
- Understanding the definition of a master case
- Guidelines for choosing master cases with diagram
- Effective practices for managing duplicates by choosing a master case
Table of Contents
Master Case: An Overview
Duplicate cases are typically managed by merging two or more cases into a single Master Case.
A Master Case is chosen from existing or creating a new case following identification of duplicates, to merge all relevant information is consolidated. This merging process is essential for maintaining accuracy and efficiency.
Choosing or Creating a Master Case
Before concluding whether choosing or creating a Master Case, first it must be validated as what is the best approach suits your case.
The process can follow one of these approaches:
- Allotting an Existing Case: The Master Case can be one of the existing cases. Relevant information from the duplicate cases is added unless it is already present or a more precise version exists in the selected Master Case.
- Creating a New Case: A new Master Case can be a new one, combining all relevant information from the duplicate cases into a single, comprehensive record.
“Managing duplicates ensures clarity, accuracy, and the integrity of your data.”
Allocation of a Master Case
- Allocating a master case involves designating one of the confirmed duplicate cases as the master case, which retains its status as a valid case.
- The other (duplicate cases) should remain in the database, labeled as “invalidated/inactivated.” These cases are preserved for audit purposes but will not be reused for any future pharmacovigilance activities.
- The selection of the master case can be based on several factors, including the case received first, the case containing the most detailed information, or the case that has already been transmitted to external partners.
- If no significant new information is added to the master case, no submission is required for it.
Creation of a Master Case
- When creating a master case, it is essential to document the case identifiers and the sources of the duplicate cases in the ICH-E2B(R2) data field, ensuring all relevant information from the subordinate duplicate cases is captured.
- The subordinate duplicate cases should remain intact, linked to the newly created master case, until they are fully reviewed and any new follow-ups are received.
- During this process, only the master case proceeds with further case processing with any coming subsequent follow-ups.
Handling Follow-Up Reports
When follow-up (FU) information is received for any duplicate cases, the master case must be updated accordingly:
- Evaluate and incorporate the follow-up information from any subordinate duplicate cases into the master case unless the same or more precise information is already present in the master case.
- For allocated master cases, maintain the worldwide unique case identification number (ICH-E2B(R2) data field) in the master case for any follow-ups.
- For created master cases, subordinate duplicates should be updated automatically based on new ICSRs. All newly received information must be evaluated, and the master case updated manually to ensure accuracy.
Best Practices for Handling Master Cases
- Perform regular duplicate screenings to identify potential duplicates.
- Validate and confirm duplicate cases.
- Document cases that are confirmed as non-duplicates.
- Monitor submission intervals and track submission times.
- Allocate or create master cases strategically and accurately.
- Inactivate or invalidate subordinate duplicates after processing.
- Validate the significance of each master case thoroughly.
- Archive invalidated or inactivated cases systematically for audits.
- Expedite the submission of master cases to EDI partners as quickly as possible.
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Key Takeaways
The master case should facilitate all pharmacovigilance activities, including signal detection and medical review of ICSRs.
The creation of a master case must comply with ICH-E2B(R2) data field requirements.
Every master case should reference all case identifiers from subordinate duplicates for easy tracking.
All relevant information, including data from subordinate cases, must be included unless it is redundant in the master case.
Even if reporter details differ for identical cases, they may still be considered duplicates.
Conclusion
This comprehensive guide offers detailed insights into effectively managing duplicate cases and handling master cases. It clarifies the concept of a master case, how to choose one, and the essential steps to follow during the process.
If you find any inaccuracies or feel we’ve missed critical details, please share your feedback. Your constructive criticism helps us improve and refine our content.
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