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Introduction to Clinical Investigation Role of the General Clinical Research Center (GCRC) in Clinical Research October 18, 2005. The General Clinical Research Center.
“…dedicated to the advancement of scientific investigation of normal and abnormal human physiology with the goal of advancing knowledge of causes, prevention, control and cure of human diseases.”
A: Investigator-initiated, “pure research” studies; subjects/patients admitted solely for purpose of participating in the research study
B: Investigator-initiated studies utilizing patients admitted to hospital for medical care
D: Industry-initiated or sponsored studies; sponsor pays expenses
* Diabetes, Neurology,
Cystic Fibrosis, G.I.
Principal Investigator: Arthur “Tim” Garson, M.D., M.P.H.
Program Director: Eugene J. Barrett, M.D., Ph.D.
Associate Program Directors:
William S. Evans, M.D.
Dan Haisenleder, Ph.D.
Mary Lee Vance, M.D.
Administrator: Pamela F. Sprouse
Nursing Coordinator: Sandra Ware-Jackson, R.N.
Director: Dan Haisenleder, Ph.D.
Manager: Pattie Hellmann
Technicians: David Smith, Sally Rittenhouse
…..to provide cost-effective assay services to GCRC investigators with exemplary quality assurance
Services offered by the laboratory:
Dietitian:Jessica Rodriguez, R.D.
Chefs: Rick Friend, Dornita Herndon, Vanda Mattysse
Informatics Manager: Martin T. Phillips, B.S.
Biostatisticians: RD Abbott, Ph.D., DG Boyd, M.S.,
JT Patrie, M.S.
Biomathematician: Michael L. Johnson, Ph.D.
-Cluster -Pulse -HyperGeo -Cross ApEn
-Deconv -Pulse2 -ApEn
Director: Arthur L. Weltman, Ph.D.
Director: Paul M. Suratt, M.D.
An optimal training program would include:
Master’s Program in
Health Evaluation Sciences
Multidisciplinary Training Program in Clinical Investigation (MTPCI)
Required Core Courses:
Introduction to Clinical Investigation
Introduction to Biostatistics
Fundamentals of Epidemiology
Chosen with guidance from the trainee’s Mentoring Committee from any school within the University of Virginia
Special Notes: women/minorities
Criteria for inclusion/exclusion
Source of research material
Numbers of patients/days
In support of current work
Previous work by PI
Protocol sent to GCRC
Assigned to a primary and secondary reviewer
Reviewers discuss their thoughts, concerns with PI and send reviews to GCRC Advisory Committee
PI meets with Advisory Committee to address concerns raised by reviewers
Advisory Committee votes on protocol
Protocol disapproved or tabled
Concerns appropriately addressed by PI