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Geri Foster, DPh Compounding & Investigational Drug Pharmacist . July 20, 2001, Friday Johns Hopkins Death Brings Halt To U.S.- Financed Human Studies . Warning letter to Johns Hopkins. No IND submission Didn’t mention all risks in consent Failed to report adverse reactions
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Compounding & Investigational Drug Pharmacist
Johns Hopkins Death Brings Halt To U.S.- Financed Human Studies
DEPARTMENT: INSTITUTIONAL REVIEW BOARD POLICY NUMBER: XI.A SECTION: Investigational Drugs, Biologics & Device REVIEW RESPONSIBILITIES:IRB Policy & Procedure Committee ORIGINAL CREATION DATE: February 04, 2002 REVISION DATES October 17, 2003
Subject: Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics in Clinical Trials
It is the policy of the Vanderbilt University Institutional Review Board that all investigational drugs, agents and/or biologics used in human subjects research be stored, handled, and dispensed in accordance with governing regulations and Institutional policy.
I.A. It is the responsibility of the Investigator to comply with all Institutional, State and Federal regulations in regards to storage of investigational drugs, agents, or biologics.
1. B. Investigational drugs, agents, or biologics used in the context of research, may be stored in areas other than the IDS under the direct supervision of the Investigator and is in accordance with the sponsor, if applicable.
I. C. Controlled substances may not be stored outside of the pharmacy department.
I. D. Investigational agent storage facilities outside of the IDS must be in compliance with Institutional, State, Federal [Food and Drug Administration (FDA)], and Joint Commission on Accreditation of Hospital Organizations (JCAHO) requirements. Pharmacy monitoring may be incorporated into the IRB auditing process as needed to assure compliance.
II. A. All investigational drugs, agents, or biologics administered to inpatients should be dispensed through the IDS pharmacy. This includes all inpatient beds in the
Vanderbilt University Medical Center,
Clinical Research Center,
Stallworth Rehabilitation Hospital,
Psychiatric Hospital at Vanderbilt
Critical Care Pharmacy
MM.7.40 Investigational medications are safely controlled and administered.
Specifying that when pharmacy services are provided, the pharmacy controls the storage, dispensing, labeling, and distribution of the investigational medication
Phil Johnston, Pharm.D.
Assistant Director of Pharmacy
Hope Campbell, Pharm.D., BCPS, Coordinator of IDS
Geri Foster, D.Ph.
Lori Choate, Certified Pharmacy Technician
Deborah Allen, Certified Pharmacy Technician
Investigational Drug Service Department of Pharmaceutical Services
1161 21st Avenue South, VUH RM B-101 Nashville, TN 37232-7610
Phone: (615) 343-6537 Fax: (615) 322-6643
Investigational Drug Prescription
Ketamine Nasal Spray versus placebo to decrease narcotic usage
Principal Investigator: Pretend, MD
Co-Investigators: Geri Foster, DPh
Patient name:___________________ Date:________________
Ketamine 25 mg/mL or Placebo
Treatment one: Date: ____/____/____
Treatment two: Date: ____/____/____
Deliver to GCRC S-3100 or E-507
Patient meets study criteria and copy of informed consent signature page is attached.
Study Authorization Order
Future - Radiation