Hopefully someone can help - I'm setting up a trial for Intensive Care patients (with low platelet count & due to undergo standard procedure), we plan to administer a drug prior to their procedure to reduce bleeding risk. Does anyone have experience of a similar trial setting - as I wondered if it would be acceptable to specify that only SAEs related to the trial treatment (i.e. adverse reactions which aren't expected and/or are serious) should be reported to the Sponsor? Follow-up is for 28 days post-treatment so I am concerned we will end up with numerous SAEs which are not relevant. Any advice would be welcome.

Thank you,