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

2/22/96 Study Organization page 16-6
findings from the CLEK Study may be released to the Study investigators, to
Study patients, and to the vision community. This committee also oversees the
informed consent process, major changes to the protocol, and Participating Clinic
performance.
The Data Monitoring and Oversight Committee meets once a year for
discussion of accumulating data. Additional meetings are scheduled as
necessary.
16.4.1 Data Monitoring and Oversight Committee Membership
The voting members of the Data Monitoring and Oversight Committee are
not otherwise involved in the conduct of the Study. They are:
• One biostatistician/epidemiologist
• One optometrist
• One ophthalmologist
The voting members are appointed by the Director of the National Eye
Institute, with input from the CLEK Executive Committee. Members who miss
two consecutive meetings are subject to replacement. All members are expected
to file statements with the Study Chairman describing any personal or
professional involvement with manufacturers or others who might benefit
financially from the findings of the Study.
In addition to the voting members, the Data Monitoring and Oversight
Committee also includes non-voting members who serve by virtue of their roles
in the Study. These are:
• Study Chairman
• Director of the Coordinating Center
• National Eye Project Officer
The Chairman of the Data Monitoring and Oversight Committee may
invite other individuals to attend one or more meetings in order to advise the
Data Monitoring and Oversight Committee on the Study design and procedures
when necessary for proper interpretation of the data.
16.4.2 Data Monitoring and Oversight Committee Functions
The specific functions of the Data Monitoring and Oversight Committee
are to make recommendations to the Director of the National Eye Institute and to
the CLEK Executive Committee regarding issues such as: