Pharmacy Services: Bayview Campus 
August 2003

The Pharmacy Service for Clinical Investigations (PSCI) provides support to investigators on the Bayview Campus through the Main Hospital Pharmacy. A satellite pharmacy was opened in the JHAAC on March 10,2004.

The PSCI has dedicated personnel to support research. The services provided include, but are not limited to:
-Study Drug Preparation & Dispensing
-Subject Randomization
-Placebo Preparation & Blinding
-Drug Information
-In-service on drug research topics
-Drug Acquisition
 

Fee Assessments are provided to investigators after review of the full protocol & all consent forms is completed. The time and cost impact on the pharmacy services are categorized accordingly:

Study Setup & Initiation:
-This fee occurs only once. It pertains to the time involved in reviewing the protocol, developing dispensing procedures, in-servicing staff, attending start up meetings, etc.;

Study Maintenance & Termination:
-This pertains to the cost of procuring drug (when applicable), Inventory control, Site visits (when applicable), etc.;

Study Drug Preparation & Dispensing:
-This pertains to the time involved for enrollment, preparation and dispensing of study drug. This also includes the cost of miscellaneous supplies used that are not supplied by the sponsor of the study.

All billing will be a reflection of the work done during the indicated period.

Auditing
Research protocols involving Investigational New Drugs (INDs) that are not dispensed by the PSCI must be audited by the Research Pharmacy. Routine audits will be conducted at initiation, shortly after patients are enrolled, prior to yearly IRB renewal and upon termination of the protocol. This is to ensure that the storage, control, preparation and dispensing of drug used in clinical trials meet all regulatory and hospital requirements.

For further information please call (410) 550-2747 or contact the Research Pharmacist at the following e-mail address: jmonola@jhmi.edu.