This blog covers:
- How to select receipt dates
- Situations that require specific receipt dates
- Different approaches to choosing receipt dates
Table of Contents:
Introduction
Receipt dates should be given top priority as soon as a report received and filed for further action.
Having discussed already about the basics and importance of receipt dates in pharmacovigilance.
This blog explore into analyzing how to capture receipt dates across various scenarios. In which can be more complex than initially apparent.
Picking Receipt Dates
Capturing receipt dates is crucial and bit confusing, as errors or omissions can heavily impact case submissions.
Receipt dates play a vital role in pharmacovigilance and need careful in selecting for each case.
Many people may face confusion when selecting receipt dates, whether during the book-in process or for cases beyond the initial ones.
So article will hep by providing detail and nuances with clearer guidance.
Let’s get started.
“Receipt dates in pharmacovigilance are not just dates; they are the anchors that ensure regulatory compliance and accurate case tracking.”
Various Scenarios, Various Receipt Date Choices
We will examine a few scenarios that you, as a case processor, may frequently encounter.
- For Initial Cases
- For Follow-Up Cases
- For Combined Reports
- For Merging Of Cases
- For Case Corrections
Receipt Dates for Initial Cases:
Initial reports are the creation or filing of a new case for a specific patient.
As previously discussed, for initial cases, receipt dates are generally straightforward.
The initial receipt date is when the report gets aware to the manufacturer.
And the date when the report is centrally received considered the safety receipt date.
Central: Processing unit
Example:
If an adverse event is reported/received on January 12, 2023, and is transferred or routed to the central office on the same day.
In this cases both receipt dates will be the same.
However, in some cases, the safety receipt date might differ from the initial receipt date.
Receipt Dates for Follow-Up Cases
Follow-up cases are similar to initial cases in that they involve straightforward receipt date selection.
IRD: The additional report comes aware
SRD: Received centrally
However, follow-up cases will also have record of two receipt dates beyond those of the initial report.
It does mean every report has its own receipt dates for identification.
Essentially, the follow-up report is treated as an additional entry in the existing case.
Receipt Dates for Combined Reports
This scenario slightly differs from the previous two but incorporates elements of both.
What are Combined Reports?
Combined reports involve the processing of two different reports that are either received on different dates or on the same day.
It is the condition, the extra report received when existing report is still in your workflow and has not yet been routed for submission.
It defines that it has not yet reached the submission stage.
Picking receipts:
In this combined scenario, you should:
- Keep the MRD/IRD (Initial Report Date) which is earlier
- Amend the Central Receipt Date (CRD) to reflect the most recent report
This approach ensures accurate tracking and processing while handling multiple reports.
Clearly mentioning in a narrative is always advisable.
Receipt Dates for Merging Cases
When the cases merged, both the receipt dates should correspond to the date when the duplicates are identified.
Receipt dates should be updated for both the retained and for deactivation cases to reflect this identification.
Receipt Dates for Case Corrections
All the case corrections required receipt dates, it purely depends on the information added.
For also case corrections require receipt dates. Typically, the receipt dates used for corrections differ from those in the original case.
Use the most recent significant initial Report Date (MRD/IRD) and leave the safety Receipt Date (CRD/SRD) blank.
✍️ Note: Some companies may amend both receipt dates, but it is always best to follow your company’s specific conventions.
Key Takeaways
Inaccurate receipt dates are a common cause of delayed regulatory submissions.
The method for selecting receipt dates varies by scenario.
The responsibility for picking receipt dates extends beyond just the book-in stage.
Receipt dates not only indicate case registrations but also record any subsequent changes.
Conclusion
From this discussion, you should have gained valuable insights into selecting the correct receipt dates for various scenarios and become more aware of the complexities involved.
Always prioritize accuracy with receipt dates and avoid compromising them, as they play a crucial role in regulatory submissions.
We hope this blog has been helpful and provided clarity on your concerns. If you have any recommendations or further questions, please let us know. We are eager to explore more topics in depth and welcome your feedback.
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