V. Policy and Procedure for Investigational Drug Dispensing* Investigational Drug Studies

1. 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 (often obtained at the investigator’s start meeting).

 

2. In order to assure that all research medications are stored in a secure, locked, limited-access area, the principal investigator should have all shipments of study drugs sent to the Research Pharmacy. The prinicpal investigator should instruct the pharmaceutical company to ship all investigational drug material to the following address:

 

Beth Israel Deaconess Medical Center

330 Brookline Avenue

Boston, MA 02215

Feldberg Research Pharmacy

ATTN: Research Pharmacist

3. 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

.

4. 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 (IRB application, Section B) to the patient’s chart.

 

*Department of Pharmacy, Investigational Drug Service

For more information regarding this process, please contact Research Pharmacist (667-4249)

                                                                                                      VI. Investigator Responsibilities