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 case study 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.

References: http://docs.oracle.com/cd/E69029_01/doc.801/e68646/e2bcheck.htm

http://www.clinicalresearchsociety.org/forum/pharmacovigilance/what-is-meaning-of-icsr/

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