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

2/22/96 Chapter 15 Coordinating Center page 15-2
15.2 Protocol Development Phase
This phase begins at funding of the Coordinating Center and represents a set of
activities that must be completed before Study patients can be enrolled.
The Coordinating Center plays an active role—along with the Chairman’s
Office, the Executive Committee, and the CLEK Study Group—in the development of
the CLEK Study protocol. This includes the following:
• Complete sections of the CLEK Operations Manual that require further
refinement and development;
• Pretest and refine forms and data entry/editing/management programs
for study administration (patient logs) and data collection at Clinics.
Forms have been field tested at 5 clinics and revised once. The forms
continue to be refined. Procedures for training and certification of CLEK
Study personnel is developed from this experience base. Programs are
completed for generating recurrent reports, trial administration and
database management;
• Certify Coordinator and Readers at the CLEK Photography Reading
Center on the CLEK Study protocol;
• Conduct a dry run of non-study photographs at the CLEK Photography
Reading Center to test each phase of the operation from logging data and
grading to transmitting data to the Coordinating Center;
• Supply Clinics with forms and documentation for the purpose of study
administration (scheduling, logs) data collection, entry and editing at the
time of the initial training meetings; and
• Prepare the first report to Data Monitoring and Oversight Committee.
15.3 Recruitment and Follow-up Phase
15.3.1 Activities
This phase is the heart of the study and is projected to cover five years from the
time of initial patient recruitment up to completion of follow-up visits (closeout). This
phase includes the following:
• Patient eligibility determination and enrollment;