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[Music] foreign [Music] hi my name is Elena and I work as a medical writer at MD clinicals and today we wanted to discuss whether clinical professionals get sufficient input from the risk management process when they start a clinical evaluation or when writing a clinical investigation without a protocol yeah yeah it is the problem that we see all the time and I do think that there is theres a problem of working in silos and I think Ive said that already in other of my videos the risk management is done by a team and the medical writing or the clinical investigation part is done by another team and in several companies we see theres not enough communication so we get an output from risk management that we go like okay we should take that in as our basis for our safety claims and so on and uh and and have some quantitative data that we can base also our endpoints on for uh or our thresholds during clinical investigations and um we we very often get like a raid with vague percentages