Pharmacovigilance (PV)
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This query is in relation to the new SUSAR submission from MHRA – ICSR Submissions.We have been told that it is possible to submit using ICSR, and then download an XML file which can be uploaded to EVWEB.My colleague has had the following experience;“I submitted a SUSAR via ICSR and attempted to upload the XML file to EVWEB. When doing this I got the following error: ‘Schema valid XML file. However, this file contains a data element that is not expected to be repeated.’
I then submitted the SUSAR in EVWEB and attempted to see whether it would work in ICSR and got the following error: ‘You cannot upload a report for an organisation you do not belong to.’
I just want to see if anyone has been successful in getting a XML file to work in either ICSR or EVWEB. Currently, we’re doing double entries and double QC’s for SUSARs on both systems, so if anyone has any guidance or even instructions that they could pass over so that we can be successful in having to just enter and QC one SUSAR which works on both systems, that would be great.”
Does anyone have any experience to share in relation to this?
As yet, there is no guidance or training on submissions available from the MHRA.
If you do have anything to impart, we would love to know about it? Many thanks!
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