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

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2/1/99 CLEK OM Table of Contents page 6 PAGE 11.3 Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1 11.4 Handling of Film after Photography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 11.5 Film Utilization for CLEK Photography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Chapter 12 Certification Procedures 12.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1 12.2 Certification for Visual Acuity Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 12.3 Certification for Refraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 12.4 Certification for Keratometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4 12.5 Certification for Corneal Topography (Video-keratography) . . . . . . . . . . . . . . . . . . 12-5 12.6 Certification for Slit Lamp Biomicroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5 12.7 Certification for First Definite Apical Clearance Fitting Protocol . . . . . . . . . . . . . . 12-6 12.8 Certification for Corneal Photography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7 12.9 Certification for Study Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8 12.10 Certification for Contact Lens Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8 12.11 Recertification for Year 12 Annual Visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9 Chapter 13 Chairman’s Office and Participating Clinic Operations 13.1 Chairman’s Office Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 13.1.1 Per-Patient Payment to Participating Clinics . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 13.1.2 Per-Patient Payment to Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 13.2 CLEK Study Newsletters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2 13.3 Introduction to Participating Clinic Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2 13.4 Eligibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3 13.5 Baseline Visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3 13.6 Annual Visits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-4 13.7 Repeat Visits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5 13.8 Completion of the Patient-Completed Forms and the Medical History Portion of the CLEK Examination Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5 Chapter 14 CLEK Photography Reading Center (CPRC) Procedures 14.1 Organization of the CLEK Photography Reading Center . . . . . . . . . . . . . . . . . . . . . . 14-1 14.2 Photography Schedules for Participating Clinics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2 14.3 CLEK Photography Reading Center Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3 14.4 Repeat Photography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3 14.5 Certification of CLEK Photography Reading Center Personnel . . . . . . . . . . . . . . . . 14-4 14.5.1 Certification of Photograph Readers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4 14.5.2 Certification of CPRC Coordinator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-5 14.6 Summary of CLEK Photography Reading Center Procedures . . . . . . . . . . . . . . . . . 14-5
2/1/99 CLEK OM Table of Contents page 7 PAGE Chapter 15 Coordinating Center 15.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-1 15.2 Protocol Development Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2 15.3 Recruitment and Follow-up Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2 15.3.1 Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-2 15.3.2 Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-3 15.3.3 Reports Prepared by the Coordinating Center . . . . . . . . . . . . . . . . . . . . . . . 15-4 15.4 Analysis of Baseline Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-5 15.5 Patient Closeout Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6 15.6 Termination Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6 15.7 Form Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-6 15.8 Records Flow Within the Coordinating Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-7 15.9 Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-8 15.10 Dataset Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9 15.9.1 Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9 15.11 Electronic Mail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9 15.12 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-10 Chapter 16 Study Organization and Policy Matters 16.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-1 16.1.1 CLEK Clinics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-1 16.1.2 Coordinating Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-1 16.1.3 CLEK Photography Reading Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-2 16.1.4 CLEK Topography Reading Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-2 16.1.5 CLEK Executive Committee and the Study Chairman . . . . . . . . . . . . . . . . 16-2 16.1.6 National Eye Institute Program Office . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-2 16.2 Study Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-3 16.3 Executive Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-3 16.3.1 Executive Committee Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-3 16.3.2 Executive Committee Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-4 16.4 Data Monitoring and Oversight Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-4 16.4.1 Data Monitoring and Oversight Committee Membership . . . . . . . . . . . . . 16-5 16.4.2 Data Monitoring and Oversight Committee Functions . . . . . . . . . . . . . . . 16-5 16.5 Patient Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-6 16.6 Patient Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-6 16.7 Publicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-7 16.8 Editorial Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-7 16.8.1 Publication of Study Design, Methods, and Findings . . . . . . . . . . . . . . . . . 16-7 16.8.2 Presentations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-9 16.8.3 Publications from Ancillary Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-9 16.8.4 Publications Concerning Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-10 16.9 Ancillary Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-10 16.9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-10 16.9.2 Definition of an Ancillary Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-10
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OM t of c.iii - Vision Research Coordinating Center - Washington ...

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