Dispensing, dosing and return of investigational product/study drug

Responsibility for accountability for investigational products/study drugs (IP) at the trial site rests with the investigator/PI, although where allowed/required the investigator may/should assign some or all of his/her duties to an appropriate pharmacists or another appropriate individual under his/her supervision. Adequate records must be maintained of the IP delivery to the site, the inventory at the site, and use by each participant. This procedure therefore describes the process for dispensing and dosing of IP and their return to a pharmacy/drug store for a clinical trial.