As a non-commercial sponsor working with Industry we are increasing being asked, in contracts, to send all SAE reports to the commercial partner (who supplies IMP and/or finance) within 24 hours of awareness. In early phase studies (I &II) with unlicensed product this can seem reasonable. However in later phase studies with licensed products we are reluctant to agree to this as it does not seem to be proportionate to the risks involved and greatly increase the burden on us in reporting terms. In these later phase studies we often attempt to say we will report all adverse reactions within 24 hours and will send quarterly line listings of SAE - but increasingly it seems that this is not acceptable to commercial partners. Additionally, very often the protocol does not describe this and by the time these negotiations come to a head the protocol has already been REC / MHRA approved and we are unsure, if we agree to this, whether or not we then also need to amend the protocol. This is more work for everyone and tends ot delay the start-up.

Does anyone know if there is specific legislation or guidance that commercial companies are following in this respect when they are not the study sponsor. I have asked but not had a satisfactory reply other than this is "company policy"!

Any feedback or infromaion appreciated.