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We are facing challenges with cases downloaded from the MHRA ICSR Submissions Portal due the size of the cases and the number of follow ups being received. Cases are typically more than 50 to 100 pages (we have received one case which is 740 pages), can have up to 40 reporters, up to 30 events and up to 60 follow up versions. This requires a lot of manual effort as the cases are not imported directly into the Global Safety Database. The cases also have to be reviewed manually to identify new information. How are other companies handling these cases?
From a PIPA Committee member perspective our respective companies all receive ICSRs electronically via gateway and therefore we are unable to offer advice on what other companies who import manually may be doing. However, we will raise this question at our next PV Webinar to see if there are PIPA members from other companies on the call who import manually and may be able to offer advice. In the meantime I also suggest that it may be worth contacting the MHRA regarding this particular case to ensure there is no error as 40 reporters sounds excessive.
We are facing this same issue with many drug related details (600+) received in the XML files received eletronically via gateway. As per Oracle Support “The maximum number of Products and Events is 200 per case”, and due to this it is not possible to auto-accept cases and these reports have to be manually added to the case. How are other companies handling these cases?
An MHRA response to the queries raised by PIPA members was circulated as an eNews on 20th March 2023.
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