Investigator Manual
V. Policy and Procedures for Dispensing Investigational Drugs
The principal investigator must contact the
research pharmacy to set up a meeting to determine the extent of pharmacy
involvement in the control and dispensing of study drugs. Materials that must be
supplied to the research pharmacist prior to the meeting include the most recent
version of the company-sponsored protocol, the Investigator’s Drug Brochure, and
any drug related information.
In
order to assure that all research medications are stored in a secure, locked,
limited-access area, the principal investigator must have all shipments of
study drugs sent to the Research Pharmacy.
The research pharmacist will review
how to complete a medication order and any other pertinent information that must
be relayed to the pharmacy to randomize a patient in an investigational drug
study.
The principal investigator and
co-investigators will be held accountable for overseeing the proper
administration of the drug. The physician must also attach a signed copy of the
informed consent and any other important information pertaining to the protocol
(CCI application, Section B) to the patient’s chart.
For more information regarding this process, please contact the Research
Pharmacist (667-4249)
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The
Harvard-Thorndike Clinical Research Center is a Harvard Catalyst Research Unit
and is funded by Grant UL1 RR 025758 from the NCRR, NIH
Please send general questions about
the CRC to the
Administrative Manager.
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Webmaster.
Clinical Research Center
(CRC)
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
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