As often when I have to look in detail to the guidance, I'm discovering little surprises.
As you might know or not, the European MEdicine Agency is promoting guidance to use at best the electronic transmission of safety information including individual cases.
For that puprose EMEA with other agencies set forth a standard. The standard is divided in various section one of which is E2b (Efficacy guidelines section b of to make it simple).
Each section follows a certain series of updates and the latest one is EV 7.1 (EV stands for Eudravigilance which covvers all the resources involved in monitroing health situation in European Economic Area).
The description of what you should put in the electronic information sent is very detailed and B3.1e (lab test unit) element is mandatory if lab test result (B.3.1d) is provided.
If you fail providing the two fields together, your information is rejected.
The interesting piece is that the authority gives answers thru a working group to the industry now and then (more or less every quater we have updates). Since December 2007, the answer given to one question about B.3.1 element is not compliant with the standard provided by EMEA.
The test is related to Blood Glucose and the result is increased. the working group suggests that you send it as two fields B.3.1c (test name) and B3.1.d (result) without the B3.1.e unit.
I will be amused if one tries to send this to the agency and get the case rejected. If you do, let me know.
