- What is the use of the reportability matrix?
The reportability matrix will allows the user to select the countries where a case should be reported depending of the country where the reaction occurs and the selected product.
- Where will I set the reportability matrix?
Administration => Products Management => Reportability Matrix
- How to set the reportability matrix?
First you will select a given product (or all your products). Then you will select the country where the reaction occurs. And to finish you will select the country where the case should be reported if it occurs in the given country with the given product. You can choose the type of formular to send and add conditions, if a case is serious, expected, related or not and decide the deadline in number of days from the last receipt date.
- Which are the fields that impact the reportability matrix?
- A.1.2) Country where the reaction/event occurred from the tab A.1 identification of the case safety report
- The seriousness criteria from the tab B.2 Reaction/ events
- The Relatedness combination must be done then complete the result (related/not related) in the tab B.4.k.18 Relatedness of drug to reaction(s) / event(s)
- The expectedness combination must be done then tick if the reaction was unexpected or not in the tab B.4.k.18 Relatedness of drug to reaction(s) / event(s)
- How does the countries where the case should be reported are coded in the case?
In the tab of the most recent information, the deadline entered is calculated from the last receipt date and the delay you entered in the reportability matrix.
