10th Sep 2012, 02:14 PM
NIMP in trial being used off license - is this ok?
We have set up an oncology trial using one IMP in combination with 'standard therapy within PL' - these therapies are classed as NIMPs currently. An amendment is to be looked at soon which will state we can use one of the NIMPs weekly instead of 3 weekly as this is standard practice. The weekly use is not a licensed use - is this drug still classed as a NIMP even though its used out of its PL?
Sorry if this is obvious but I've got myself confused about IMP/NIMPs!!