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

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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
2/22/96 Study Organization page 16-8 CLEK Study patients are not billed for Study-related visits and are reimbursed $20 for each Study Visit for personal expenses. Usual and customary fees apply for non-Study-related eye and vision care, including contact lens and surgical care.
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OM t of c.iii - Vision Research Coordinating Center - Washington ...

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