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103.20 Organization Policy Investigational Drug Service (IDS) and OHSR

August 2010

The Organization requires the Investigational Drug Service (IDS) procedures to protect subjects enrolled in studies involving drugs, biologics, botanicals, complementary and alternative medicines (CAMs), and other substances.  The Organization has an IDS at each campus.  The IDS staff has been delegated responsibility for assuring that the receipt, dispensing, and record keeping requirements for investigational drugs conform to Organization requirements.  OHSR staff will share with IDS information regarding investigational drugs used in research protocols.  In addition, staff of the IDS will have access to the eIRB system and OHSR database to facilitate this communication and will report audit results to the OHSR.