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

2/22/96 Chapter 12 Certification page 12-1
12.1 Introduction
Chapter 12
Certification Procedures
The purpose of certification requirements in the CLEK Study is to assure that
procedures are being performed in accordance with the CLEK Study protocol in
each Clinic. Certification is supervised by the Executive Committee and its
designates.
The Executive Committee oversees certification, issues certification
documents and reports any deviation from protocol to the Executive Committee.
Prior to enrolling any CLEK Study patients or collecting any CLEK Study
data, each Clinic must have at least two individuals certified to perform each of the
tasks listed below. The CLEK Executive Committee encourages both individuals to
participate actively in examining CLEK Study patients, and in order to be recertified
each year, each individual must process at least 10 CLEK Study patients in
a calendar year.
The key CLEK Study tasks requiring certification are:
• Visual acuity
• Refraction
• Keratometry
• Videokeratography
• Slit lamp evaluation
• Corneal photography
• First definite apical clearance lens (FDACL), contact lens fit assessment, and
fluorescein photography
• Study coordination
• Contact lens verification
CLEK Photography Reading Center certification procedures are described in
Chapter 14.
In order to maximize stability of CLEK Participating Clinic personnel and to
enhance data quality, trainees at Participating Clinics (eg, optometry students,
optometry and ophthalmology residents, optometry and ophthalmology fellows)
cannot be certified as CLEK Participating Clinic personnel. Exceptions must be
approved by the Study Chairman.