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

2/22/96 Study Organization page 16-14
16.9.3 Rationale for Approval Requirement
Everyone involved in the CLEK Study is entitled to prior assurance that
no ancillary study will:
• Complicate the interpretation of CLEK Study results;
• Adversely affect patient cooperation or recruitment;
• Jeopardize the public image of the Study; or
• Create a serious diversion of Study resources locally, at the Coordinating
Center, or at any other of the Resource Centers serving the whole CLEK Study
Group.
16.9.4 Preparation of Approval Request for Ancillary Study
The request for approval of an ancillary study involves two steps. The first
requires a brief description of the proposed ancillary study in narrative form
stating the primary hypothesis and a brief description of the study which
addresses the issues in Section 16.10.3 (above). This brief description is sent to the
Study Chairman and reviewed by the Executive Committee within one month of
receipt. If approved for further consideration, a detailed description should be
submitted in narrative form following the standard PHS-398 format and must
provide information on the additional patient burden imposed by the ancillary
study informed consent procedure, extra time, extra visits, etc. It should contain
a description of the objectives, methods, and significance of the ancillary study.
Full details should be given concerning any procedures to be carried out on any
CLEK Study patients, such as laboratory tests, psychiatric interviews,
psychological testing, etc. Mention should be made of any substances to be
injected or otherwise administered to the patients. Any observations to be made
or procedures to be carried out on a patient outside of the Clinic should be
described.
Detailed information should be given concerning the extent to which the
ancillary study will require blood or other specimens. If specimens are to be
obtained from the patients, mention should be made of all procedures to be
carried out on these specimens.
If access to CLEK Study data is required, the investigator must specify
what data are needed, on whom it is needed, and the timetable for access to such
data. Access to CLEK Study data requires approval by the Data Monitoring and
Oversight Committee.