20th Aug 2015, 08:26 PM
Transfer of IMP w/out PL.
I'm trying to arrange the transfer of IMP, currently excess to requirements for a (closing) CTIMP, to a new, non-CTIMP study where it will be used as an imaging agent. The IMP has had it's PL withdrawn during the course of the CTIMP. The CI (same for both studies) doesn't feel that it is necessary to seek QP opinion for the transfer, nor to ask the drug manufacturer if the transfer is acceptable to them.
I would welcome the forum's thoughts on this.