Pharmacy and Investigational Drug Service (IDS) at The Johns Hopkins Hospital August 2004 Research at The Johns Hopkins Hospital is supported by three main research pharmacies within the Department of Pharmacy: Investigational Drug Service (IDS): Location: Osler 100 Hours of operation: Monday through Friday 7:30 a.m. to 5:30 p.m. Phone: 410-955-6337 or 410-955-4505 Fax:410-614-8074 Oncology Research Pharmacy: Location: Weinberg Bldg, Room 2432 Phone: 410-502-1036 or 510-955-8998 Fax: 410-955-6371 Pediatric Research Pharmacy: Location: CMSC 209 Phone: 410-955-5926 or 510-502-7426 Fax: 410-955-0283 Investigational New Drugs (INDs) for inpatient research studies must be dispensed by the Pharmacy. Investigational New Drugs for outpatient research studies may be dispensed by the Pharmacy or by the Investigator. When the Pharmacy controls the IND in a study, all necessary drug control and recordkeeping functions are conducted for the investigator. If an investigator wishes to retain control of an IND, the Investigational Drug Service (IDS) must audit the storage and recordkeeping system to be used for the control of the drug. Audits are performed to ensure that labeling, drug storage, dispensing and accountability records comply with federal, state, and local guidelines. The Research Pharmacy performs an audit prior to the start of the study, shortly after patient enrollment begins, upon yearly IRB approval to continue the study, and finally at the termination of the study. The Pharmacy does not charge investigators for this required auditing. The audit form used by the Research Pharmacy staff may be found here. Research Pharmacy Fees Investigators who wish to have the Pharmacy control outpatient INDs in research studies should contact the IDS staff at 410-955-6337.Supoort of a research project may include any or all of the following services: Coordinate and dispense study medication; prepare randomization lists; blind study medication; assist with development of matching placebo; drug information; patient counseling; adherence monitoring; and obtaining drug supplies. A typical study requires 30 hours for set up; and barring major revision, there is no additional yearly fee for set up of a research study. The Research Pharmacy can provide inventory management for a drug study. Inventory management includes recordkeeping requirements, tracking of the running balance for the study drug supply, and accounting for all doses dispensed. The Research Pharmacy can prepare and dispense study drug. The Research Pharmacy does charge a fee for administrative set up, inventory management, and dispensing. Please contract the IDS staff for fee information. (October 2002)
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