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

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;