Date: 06Oct2016
Why is E2B Validation important?
In Pharmacovigilance -Case processing after completing the
data entry process and before routing the case to the next workflow (Medical
Review), it is mandatory for everyone to do a Validation check called as E2B
validation, E2B validation error could also be an error associated with a
special character in Narrative or in adverse event, further if an error is
reported on Validation check which cannot be rectified, a comment stating ‘E2B
validation was noted and bypassed’ should be used contact log
Every wondered why?
Every ICSR (Individual case safety report) as per 21 CFR 314.80
in US and Schedule Y appendix XI in India, should be transmitted from the
reporting sources to the regulatory authority and this process is also known as
E2B submission (as we submitting E2B files) and because one of the mode of
transmission is via XML format, if a special character found in the ICSR which
is not rectified after the ICSR is converted into an XML file and upload as an
E2B file in the regulatory database while doing the regulatory submission it
will not accept the E2B file and prompt back with an error hence it is
mandatory to always do an E2B validation.
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