The IDS shall control and monitor the use, receipt, storage, preparation and dispensing of investigational drugs at the MFA, and GWUH for both inpatient and outpatient studies when the principal investigator assigns this duty to the research pharmacist and/or IDS staff. This is in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice whereby Sections 4.6.1-4.6.3 states “responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. Where allowed/required, the investigation/institution may/should assign some or all of the investigator’s/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution. The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product’s delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s).”
IDS will operate under the supervision of the District of Columbia Board of Pharmacy as a “closed-door specialty/limited use pharmacy” and will maintain compliance with all regulations pertaining thereto. These policies and procedures have been developed in compliance with state and federal (Food and Drug Administration) regulations and in conformance with the Joint Commission on Accreditation of Healthcare Organization’s (JCAHO) requirements and American Society of Hospital Pharmacists’ (ASHP) recommendations regarding the use of investigational drugs involving human subjects.
The IDS is accepting currently only studies with MFA primary investigators.