What is Case Receipt in Pharmacovigilance?

This blog covers the following topics:

1. Insights into receipt dates in pharmacovigilance.
2. Comprehensive overview of different receipt dates.
3. The relevance of receipt dates in follow-up reports.

Overview

This below article meant for those who may confused about a particular topic.

Yes, about the receipt dates in pharmacovigilance case processing.

Yet, if you are already familiar with the topic. In this blog you may get a chance of exploring something new about this topic.

Notification: While perusing this blog, we also provide a complimentary checklist to enhance your ICSR case processing. Feel free to access it while navigating through the content.

Receipt dates

In pharmacovigilance, receipt dates are crucial for regulatory submissions at-least in case processing.

There are two important dates that are often the same or sometimes different:

1. MRD/IRD
2. CRD/SRD

These dates mark when cases in and out in various levels.

✍️ Note: It called by various terms based on their internal naming conventions. However, mentioning here the most commonly used terms in the field of pharmacovigilance.

MRD/IRD:

MRD/IRD stands for Manufacture/Initial Receipt Date.

It signifies the initial reception of a case, when the adverse event report first comes aware. Alternatively, it can be referred to as day zero.

MRD/IRD in detail:

It’s the date when a report about a reaction or event to a specific drug submitted by a reporter or consumer.

This report is first becomes aware by the company that produce the drug.

The report either reported to:

1. Directly to manufacturer
2. To regulatory bodies
3. MAH
4. Designated department to record these reports

CRD/SRD:

CRD/SRD stands for Central/Safety Receipt Date.

This marks the date where the case received by central unit.

Here central unit signifies the safety processing unit.

This date signifies when the report received by the central unit for processing.

CRD/SRD in detail:

It is the date, once the initial report filed, i.e, what we see earlier MRD/IRD. It is then should forward to the relevant team or department (safety processing unit) for:

1. Further Evaluation
2. Assessment and
3. Submission

which mostly occur on the same day or sometime may delay.

So since you are in a case processing team, the day when the report received and registered within your department considered CRD/SRD.

This process called intake of cases. It typically booked and routed to data entry on the same day, with the order of priority.

📢 If you’re wonder to explore, click here to discover the step-by-step considerations in the book-in process.

Conclusion

Based on the above discussion, we hope that we explored something significant in deep. It is a very important factor within pharmacovigilance many not notices it.

Thumbs up if you got some clarity and we appreciate your valuable recommendations.

And also you can pin point us if we miss anything crucial.

Your comments are welcome.

References:

1. EMA GVP Guidelines