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

2/22/96 Chapter 12 Certification page 12-8
• Following the directions of the Director of the CLEK Photography Reading
Center: to photograph two keratoconus patients with at least two scarred eyes
between them and send the exposed film to the CLEK Photography Reading
Center.
After satisfactory completion of all requirements, verification of certification
is issued and forwarded by the Chairman’s Office to the Coordinating Center and
the Executive Committee. To keep certification current, the task must be
satisfactorily completed on at least 10 Study patients in a calendar year.
Probationary certification is granted in the event of unsatisfactory
performance. Full certification must be restored within a reasonable period of time,
or termination from the Study should be considered.
Annual recertification is granted by maintaining a 95% readable slide and
95% grade 2 or higher slide quality as graded by the CLEK Cornea Photography
Reading Center.
12.9 Certification for Study Coordination
The training of the personnel who serve as the CLEK Participating Clinic
Coordinators is conducted prior to start-up. Certification will be granted upon the
successful completion of certification at the time of the centralized training meeting. Full
certification may be withdrawn or down-graded to probationary certification if
performance is not satisfactory; otherwise, certification is current for one year. Certification
must be renewed by telephone annually.
The Study Coordinator’s role is critical to the smooth day-to-day operation of
the Clinic, but because of the patient flow requirements of this observational study,
the clinic coordination tasks will be assigned to a less-than-full-time person. The
training program will emphasize skills in patient management, data quality control,
and organizational ability. Similarly, the certification procedure will evaluate some
of the following skills: 1) simulated data with problems to evaluate data editing
expertise, and 2) hypothetical patient problems to evaluate familiarity with the
protocol and patient follow-up procedures. To prepare for the certification, the
Clinic Coordinator must demonstrate command of the CLEK Study protocol as
described in this Operations Manual, Chapters 2, 3, 4, 5, 6, and 13.
After satisfactory completion of all requirements, verification of certification
is issued and forwarded from the Chairman’s Office to the Coordinating Center and
the Executive Committee. To keep certification current, the task must be
satisfactorily completed on at least 10 Study patients in a calendar year.