Academic Health Center Office of Research - Pharm.D. Professional Program - University of Minnesota

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Academic Health Center Office of Research

APPE Experience Types Non-Patient Care (Elective) Address University of Minnesota, Academic Health Center, Office of Clinical Research, IND/IDE Assistance Program, 717 Delaware Street SE, Minneapolis, MN 55414 Phone 612-625-0930 Main contact Harvey M. Arbit, PharmD, MBA, RAC, CCRP Director, IND/IDE Assistance Program University of Minnesota, Academic Health Center, Office of Clinical Research 717 Delaware Street SE, Minneapolis, MN 55414 612-625-0930 Email		Region: Twin Cities AHC Site

Main Preceptor Harvey M. Arbit, PharmD, MBA, RAC, CCRP Director, IND/IDE Assistance Program Phone 612-625-0930 Email		Teaching Philosophy Learning the FDA regulations and applying them appropriately to investigator-initiated clinical trials is done through hands on experience and review of the regulations. The student is given assignments and instructions. It is up to the student to find the best answer for the situation. The answer is reviewed and discussed so the student understands the impact his/her answer has. Alternative responses are also discussed to understand their impact. The student is expected to learn to navigate the FDA’s website. It is more important to understand the regulations and apply them than it is to memorize the words.

Detailed Site Information Institution The IND/IDE Assistance Program is located on the 2nd floor of the newly remodeled 717 Delaware Street SE facility. The intern will be provided office space, computer, telephone, and access to reference materials. Institutional Mission Statement and Vision The IND/IDE Assistance Program (IAP) is a complimentary education and assistance resource for faculty researchers who are involved in human subject research. The primary objective of the IAP is, first to ensure that all University of Minnesota faculty members who need to file either an IND or IDE do so correctly and in a manner in which it will not detract from their clinical research. Second, to clarify the complex obligations and responsibilities the FDA has set forth for individuals involved in the filing of an IND/IDE. That is, to give regulatory assistance to the sponsor-investigator of the clinical investigation. Third, to help faculty researchers be compliant with the University of Minnesota Policy 2.1.10. Pharmacy Services There are no traditional pharmacy services provided at this site. The services offered involve regulatory affairs and clinical research allowing faculty researchers to conduct clinical studies in compliance with FDA regulations. Professionalism and Assessment Evaluation and assessment of the student will be done in accordance with the guidelines set forth by the College of Pharmacy. Resources Public parking, for a fee, is available at the Oak Street Parking Ramp, located on the east side of the building. The student may park elsewhere or take public transportation. All amenities of the Minneapolis campus are available to the students. Non-patient care (Elective) – Regulatory Affairs Primary Preceptor Harvey M. Arbit, PharmD, MBA, RAC, CCRP Director, IND/IDE Assistance Program University of Minnesota, Academic Health Center, Office of Clinical Research 717 Delaware Street SE, Minneapolis, MN 55455 arbit002@umn.edu 612-625-0930 APPE Structure The students will be working at the newly renovated 717 Delaware Street Building, which houses the Office of Clinical Research and other research laboratories. The students will be learning about the IND/IDE Assistance Program through the roles and responsibilities listed below. Student Roles and Responsibilities The student’s learning activities and responsibilities include: reading and discussing the FDA’s regulations and guidance documents; conducing IND and IDE assessments of applicability under the direction of Dr. Arbit; accompanying Dr. Arbit on IND/IDE meetings in the offices of faculty IND/IDE sponsor-investigators; observing and participating in instructional sessions with new IND/IDE sponsor-investigators; reviewing data in the program’s data base and presenting finding to track progress and activities of the program; and depending on time, student interest, and coordination of efforts, the student may be involved in writing a manuscript for publication in a refereed journal. Educational Opportunities The student’s learning activities and responsibilities include: reading and discussing the FDA’s regulations and guidance documents; conducing IND and IDE assessments of applicability under the direction of Dr. Arbit; accompanying Dr. Arbit on IND/IDE meetings in the offices of faculty IND/IDE sponsor-investigators; observing and participating in instructional sessions with new IND/IDE sponsor-investigators; reviewing data in the program’s data base and presenting finding to track progress and activities of the program; and depending on time, student interest, and coordination of efforts, the student may be involved in writing a manuscript for publication in a refereed journal. Other Requirements There are no prerequisites for this rotation other than the pharmacy student should have an interest in learning about drug development from a regulatory and clinical perspective and a desire to learn about alternative practice settings as a pharmacist. The student will be expected to be on site during normal working hours, 8am to 5pm, Monday through Friday. There are no evening or weekend requirements except for occasional dinner meetings and seminars. The student will not have on-call responsibilities. Also, there are no vehicle/transportation requirements for the student other than to arrive on campus.