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

2/22/96 Study Organization page 16-17
This report may be prepared as a letter. The Study Chairman reports on the
status of all ancillary studies to the Executive Committee at each meeting.
16.10 Access to Study Information
16.10.1 Study Documents
The CLEK Operations Manual and copies of the data collection forms
used in the CLEK Study will be placed in a suitable repository, such as that
maintained by the National Technical Information Service, for access by any
interested party. These documents may be referenced without prior approval
once they have been placed in the repository. The Coordinating Center Director
replaces documents in the archives with updated copies whenever substantive
changes are made in the procedures or methods, as determined by either the
Executive Committee or the Data Monitoring and Oversight Committee.
In general, the following documents may not be released to any group or
individual outside the CLEK Study Group:
• Minutes of CLEK Study meetings;
• Performance monitoring reports for CLEK Clinics and Resource Centers;
and
• Data Monitoring and Oversight Committee reports.
16.10.2 CLEK Study Data
Access to CLEK Study data on individual patients is prohibited to
unauthorized persons, whether on file in a Clinic, in the Coordinating Center, or
in the CLEK Photography Reading Center. The identity of individual CLEK
Study patients may not be revealed in any public report or presentation.