Investigational Product Management-Study Close Out
All investigational products used and unused must be accounted for by the Study Monitor. Disposal of used or unused investigational products must be initiated only after the written instruction from the Sponsor/Study Monitor had been obtained.
After the final monitoring visit, the sponsor monitor may indicate that IP destruction of any remaining product may take place. Drug destruction, and appropriate records of such destruction, are the responsibility of the sponsor. In some cases this may be an industry sponsor, CRO, other site or Penn PI for an IIT.
All investigational drugs at Penn should be maintained by Penn IDS who may be able to assist with destruction. At the start of the trial, a decision should have been made if drug will be destroyed on site or shipped back to the sponsor. Please contact IDS for onsite IP disposal.