Contract terms - SAE reporting to commercial funders when University is Sponsor

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The MAH may be developing the drug for other indications and may be responsible for preparing Investigator Brochures and DSURs. The risk benefit analysis may be altered according to information received and the MAH has a duty to inform other sponsors, investigators, ethics committee and regulatory authorities of any change in this. The safety picture of any compound does not just reply upon SUSAR reports. SAEs may alter the picture when combined with SUSARs/SAEs from other sponsors and with information in the MAH PV database. Hence they need to get information on SAEs in a timely manner. MAHs have invested a great deal in extensive PV systems. Consequently speed is very important if they want to get reporting into their system, test them, decide what needs reporting and be able to report them. Hence why they often have a "one size fits all" approach to timelines for getting reports into the system. You can negotiate terms in your contract with the MAH. However with regard to MAH reporting the MHRA has commented that:- "There is no requirement to send SUSARs to an MAH who is not the Sponsor (although the previous version of CT3 recommended this practice). It also follows that there is no requirement for MAH's to submit SUSARs from clinical trials to the MHRA, when they are not the Sponsor - this is the Sponsors responsibility. "

MHRA comment: If the MAH is not the sponsor, but is providing funding and/or IMP then a contract will likely be in place and the MAH will want to get safety information reported and will specify a timeframe. If the Sponsor enters into this agreement then they need to follow the contract - and then the reasoning in the first part of the post stands.