JOHNS HOPKINS MEDICINE

ABOUT JOHNS HOPKINS MEDICINE

HEALTH INFORMATION

PATIENT CARE

RESEARCH

EDUCATION

THE INSTITUTIONAL REVIEW BOARDS
VISIT JHM RESEARCH

Photograph of Health Professional

IMAGE OF BLOOD CELL

Photograph of Chemical Container

WHAT'S NEW AT THE IRB

Print This Page

General Information

Guidelines

Organization Policies

Notices & Updates

IRB Forms

Compliance Monitoring Program

HIPAA & Research

Research Training Requirements

Site Map

Contact Us

Alan Mason Chesney Medical Archives

Information for Research Participants

Other Resources

FAQs

Link to eIRB

Search this site:
Full AAHRPP Accreditation

Home > Guidelines & Requirements > Pharmacy and IDS Services: JHH

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)

 

 

If you have any comments, questions or suggestions
you may contact the JHM IRB at:

p: 410.955.3008 | f: 410.955.4367 or 443.287.5353 | e: jhmirb@jhmi.edu

 


Site Maps | FAQs | Maps & Directions | Privacy Policy | Intranet | Contact JHM | Media Inquires | Fund For JHM
JOHSN HOPKINS HOSPITAL & HEALTH SYSTEM
JOHNS HOPKINS UNIVERSITY
JOHNS HOPKINS MEDICINE