Clinical Trials Unit
The Clinical Trials Unit (CTU), a newly renovated, 2,600-square-foot ambulatory site located in Suite S7-714, is a comfortable and accessible area for study participants. The CTU includes a waiting area; conference room for study initiation, monitor visits and education meetings; four (4) staff offices; three workstations for visiting staff; four (4) exam rooms and an infusion room with two recliners. Staffed with an experienced, certified clinical research nurse manager, research nurse coordinators, regulatory specialist and a receptionist / research assistant, the CTU will provide high quality research coordination and management of studies. A small laboratory equipped with a centrifuge, freezer and hematocrit machine is available to investigators and their staff, as well as an area for packaging and shipping clinical trial samples to meet the current transport regulations. Working with the existing investigational pharmacy (located in the ambulatory area of UMass Memorial Medical Center - University campus), the CTU will administer study drug according to individual protocols, with drug storage and preparation remaining in the ambulatory pharmacy. A secure area for study files and case report forms on a short-term basis will be available; the investigator will remain responsible for long-term storage of study files.
The Clinical Trials Unit is under the direction of the Office of Clinical Research in the Office of Research, UMass Medical School.
An array of services are available to investigators and their staff to assist them in study initiation and ongoing study conduct. Any applicable fees* for these services will be charged through the Office of Clinical Research.
CTU services available as of November 2004 include:
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Research Nurse Coordinators - CTU-based
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Regulatory Specialist - assists investigator with IRB submissions, regulatory documentation and IND submissions
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Four exam rooms for study visits
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A private room for interview studies
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An infusion room with two recliners
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Three work stations for investigators and coordinators for computer use, lab retrieval, etc. while using the CTU
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Small laboratory to centrifuge, freeze or package and ship specimens according to regulatory transport guidelines
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Future plans:
* Fees for chosen services will be assessed dependent on funding sources and individual investigator needs. Please call
Sheila Noone, PhD
, Office of Clinical Research at 508-856-5015 for more information.
Other related and existing services through the Office of Clinical Research:
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Promoting clinical investigator interests through industry liaisons
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Assistance with feasibility review of new studies
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Careful review and assessment of clinical study budgets
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Thorough and timely review of Clinical Trial Agreements
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Educational and training opprotunities for clinical investigators, coordinators and other key personnel
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Investigational pharmacy support and consultation
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Quality Improvement Initiative
Medical Director:
John L. Sullivan, MD
Administrative Director:
Sheila B. Noone, PhD
CTU Staff and Contact Information:
Main Number: 508-856-2800
Research Manager:
Bernadette White, RN, CCRC
508-856-3674
bernadette.white@umassmed.edu
Research Nurse Coordinator:
Irene Hill, MSN, RN
508-856-2908
irene.hill@umassmed.edu
Research Nurse Coordinator:
Linnea Olson, RN, BSN
508-856-2857 or 508-856-8135
linnea.olson@umassmed.edu
Administrative Assistant:
Mary McNamara
508-856-2800
mary.mcnamara@umassmed.edu
Regulatory Specialist:
Donna Christian, M.A.
508-856-2828
donna.christian@umassmed.edu