The Pharmacy Service for Clinical Investigations (PSCI) at JHM Bayview Medical Center provides support to investigators at 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. Some of the services provided by the PSCI include:
- Study Drug Preparation & Dispensing;
- Subject Randomization;
- Placebo Preparation & Blinding;
- Drug Information;
- In-service on drug research topics;
- Drug Acquisition;
- Random Code Generation;
- Preparation of Investigational Drug Data Sheets for IRB submission;
- Assistance with Investigational New Drug (IND) FDA application preparation; and
- Coordination of pharmacy services for multicenter studies.
Fee assessments for PSCI services are provided to investigators after review of the full protocol and all consent forms has been completed.
The time and cost impact on the PSCI 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: 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; and
- Close-out Cost: This pertains to study drug return or destruction, and storage of pharmacy regulatory records.
All billing will be a reflection of the work performed during the indicated period.
Research protocols involving Investigational New Drugs (INDs) that are not dispensed by the PSCI must be audited by the PSCI. 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(s) 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: email@example.com.