MTS & a123456

many thanks for the feedback - very useful information and reference. There does not seem to be a legislated imperative to report SAE to funders within 24 hours.
It feels like, that as a sponsor we are within are right to negotiate the contract to a timeframe that is mutally acceptable and managable - it is then important to stick to that contract. I think we will now be more confident, especially with later phase studies with licensed products in saying no to reporting SAE to the funder in 24 hours, certianly as an initial position. For early phase studies or those with unlicensed product we may be within our rights to charge for this addtional activty if it becomes a condtion of funding.