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

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2/1/99 Chapter 14 CPRC page 14-7 14.6 Summary of CLEK Photography Reading Center Procedures The CLEK Photography Reading Center Operations Manual provides complete details on the following procedures: (1) Responsibilities of the CLEK Photography Reading Center Director, the CPRC Coordinator, the Readers, the CPRC Slide Labeling Technician, the CPRC Computer Programmer; (2) Training and certification of the CPRC staff, the CLEK Clinicians, and the CLEK Clinic Photographers; (3) Scheduling of fluorescein and corneal photography; (4) Fluorescein and corneal photography protocols (also in Chapters 11 and 12 of this Operations Manual); (5) Retakes of photographs; (6) Routing and processing of photographs; (7) Reading of photographs; (8) Internal quality control by the CPRC; (9) External quality control by the CPRC; (10) CPRC reports; and (11) CPRC forms.
2/22/96 Chapter 15 Coordinating Center page 15-1 15.1 Introduction Chapter 15 Coordinating Center The Coordinating Center is the joint effort of the Department of Ophthalmology and Visual Sciences and the Division of Biostatistics of Washington University School of Medicine. The Coordinating Center collaborates with the Study Chairman’s Office, the Executive Committee, the CLEK Study Group and the Data Monitoring and Oversight Committee in the design and implementation of the CLEK Study. This includes coordinating the efforts of investigators, monitoring protocol adherence, receiving, managing, and storing all CLEK Study data, analyzing CLEK Study data, and preparing reports and publications. The staff of the Coordinating Center consists of the Director, the Co-Director, the Project Manager, the Statistician, the Project Assistant, and the Senior Research Analyst. Figure 15-1 The Coordinating Center’s Organizational Scheme Director Co-Director Project Manager Project Assistant Statistician Senior Research Analyst The objective of the Coordinating Center’s work changes greatly depending on the phase of the study. The objectives of the Coordinating Center are summarized in each of the phases depicted in Table 15-1. Table 15-1. Phases of the CLEK Study. Phase Protocol Development Recruitment/Follow-up Patient Closeout Study Termination Beginning Event Funding of Coordinating Center, Chairman’s Office Start enrollment and follow-up Complete follow-up, closeout Final data analysis, publications
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