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Research at The Johns Hopkins Hospital is supported by three main research pharmacies within the Department of Pharmacy:
Investigational New Drugs (INDs) for inpatient research studies must be dispensed by the Pharmacy. INDs for outpatient research studies may be dispensed by the Pharmacy or by the Investigator. When the Pharmacy controls the IND for a study, all necessary drug control and recordkeeping functions are conducted for the investigator by the Pharmacy.
If an investigator wishes to retain control of an IND, the Investigational Drug Service must audit the storage and recordkeeping system to be used by the investigator 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 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 when the study is terminated. The Pharmacy does not charge investigators for this required auditing. The audit form used by the Pharmacy staff may be found here.
Pharmacy Support and Inventory Management
Investigators who wish to have the Pharmacy control outpatient INDs in research studies should contact the IDS staff at 410-955-6337.
A typical study requires 30 hours for pharmacy setup, and barring major revision, there is no additional yearly fee for pharmacy setup of a research study.
Pharmacy Inventory Management
The Pharmacy can provide inventory management for a drug study. Inventory management includes:
The Pharmacy can prepare and dispense study drug.
The Research Pharmacy does charge a fee for administrative set up, inventory management, and dispensing. Please contact the IDS staff for fee information.