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 CRC is funded by Grant M01 RR01032 from the NCRR, NIH
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Administrative Manager.
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Clinical Research Center
(CRC)
Beth Israel Deaconess Medical Center
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