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

2/22/96 Study Organization page 16-7
• Reviewing the design of the CLEK Study, including methods of patient
recruitment, the informed consent process, and data collection procedures;
• Evaluating the accumulating data at regular intervals;
• Determining when the data are sufficiently convincing to answer Study
questions of interest;
• Determining when data collected should be released to the Study
investigators, to Study patients, and to the ophthalmic community;
• Evaluating recruitment and monitoring overall performance of the
Resource Centers and Participating Clinics;
• Recommending to the Executive Committee changes in the Study protocol
based on periodic data analysis;
• Evaluating data and protocols for patient protection; and
• Protecting the operational and scientific integrity of the Study, including
evaluation of ancillary studies.
16.5 Patient Consent
The CLEK Study requires that written consent be obtained from each
patient prior to enrollment into the Study. The patient should be asked to sign
the consent form only after eligibility has been established and after patient
education has been completed (see Chapters 3 and 4 of this Operations Manual
for details). The signed consent form should be kept in the Clinic. The Data
Monitoring and Oversight Committee and the Project Manager may review
consent forms from time to time to assure adherence to minimum standards.
Each Clinician is responsible for obtaining approval of the consent form
from his or her local institutional review board. (See sample Human Subjects
application and informed consent form at the end of Chapter 4 of this Operations
Manual.) A copy of each Clinic’s approved consent form and documentation of
approval must be submitted to the Coordinating Center before patients can be
enrolled in the CLEK Study.
16.6 Patient Costs