OM t of c.iii - Vision Research Coordinating Center - Washington ...

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2/22/96 Study Organization page 16-1 16.1 Introduction Chapter 16 Study Organization and Policy Matters The resource centers for the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study are: (1) CLEK Clinics; (2) Coordinating Center; (3) CLEK Photography Reading Center; (4) CLEK Topography Reading Center; (4) Study Chairman’s Office; and (5) National Eye Institute Program Office. The organizational structure of the CLEK Study links resource centers together in a productive network (Figure 1-1). The organization must be selfsufficient, stable, and self-renewing in order to achieve the Study goals. 16.1.1 CLEK Clinics Chapter 13 of this Operations Manual outlines the CLEK Clinic Operations. Each Clinic is responsible for screening potential CLEK Study patients, for recruiting an adequate number of eligible patients, and for following patients according to the protocol until the termination of the Study. Each Clinic has at least one certified Clinician and one certified Back-up Clinician and at most those staff members plus one certified Technician, one certified Photographer, and one certified Study Coordinator. All Clinics are reimbursed for CLEK Study participation on a per-patient basis from the CLEK Study Chairman’s Office. 16.1.2 Coordinating Center Chapter 16 of this Operations Manual contains the Coordinating Center’s operating plan. The Coordinating Center at Washington University Medical School (St. Louis) is responsible for: (1) Development and implementation of the study design;
2/22/96 Study Organization page 16-2 (2) Receiving, editing, processing, analyzing and storing the data generated in the CLEK Study; (3) Coordinating data generation activities of the Clinics and the CLEK Photography Reading Center; and (4) Implementing and maintaining quality assurance procedures to minimize bias and error. The Coordinating Center personnel include the Director, the Co-Director, the Project Manager, the Project Assistant, the Statistician, and the Senior Research Analyst. 16.1.3 CLEK Photography Reading Center (CPRC) Chapter 14 of this Operations Manual and the CLEK Photography Reading Center Operations Manual describe the goals and day-to-day operations of the CPRC in detail. The CLEK Photography Reading Center, located at The Ohio State University College of Optometry, is responsible for receiving all fluorescein photographs and corneal photographs and grading them according to specific procedures and criteria described in the CLEK Photography Reading Center Operations Manual, maintaining records of photography data, and transmitting grading results to the Coordinating Center. The CLEK Photography Reading Center consists of the CPRC Director, the CPRC Coordinator, and two Readers. 16.1.4 CLEK Topography Reading Center (CTRC) Chapter 8 of this Operations Manual and the CLEK Topography Reading Center Operations Manual describe the goals and day-to-day operations of the CTRC in detail. The CLEK Topography Reading Center, located at the University of Illinois at Chicago Department of Ophthalmology and Visual Sciences, is responsible for receiving all videokeratographic images and grading them according to specific procedures and criteria described in the CLEK Topography Reading Center Operations Manual, maintaining records of videokeratography data, and transmitting grading results to the Coordinating Center. The CLEK Topography Reading Center consists of the CTRC Director, the CTRC Programmer, the CTRC Technician, and the CTRC Biostatistician. 16.1.5 CLEK Executive Committee and the Study Chairman
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OM t of c.iii - Vision Research Coordinating Center - Washington ...

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