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

2/22/96 Study Organization page 16-16
16.9.5 Procedures for Obtaining Ancillary Study Approval
The investigator proposing an ancillary study should send a written
request (described just above in Section 16.11.4) to the Study Chairman, who is
responsible for distributing copies to all members of the Executive Committee.
Within a reasonable time the Study Chairman summarizes questions and/or
objections raised by members of the Executive Committee and sends this
summary to the applicant for amplification, clarification, or withdrawal of the
request. The members of the Executive Committee have another opportunity to
review the request. If the Executive Committee then approves the ancillary study
proposal, the Chairman prepares a statement of the Executive Committee
consensus, including any remaining reservations or objections, and makes a
recommendation to the Data Monitoring and Oversight Committee, which is
responsible for review and recommendation of ancillary studies. The Chairman
then notifies the investigator proposing the ancillary study of the decision.
16.9.6 Funding of Ancillary Studies
If no additional funds are required, the investigator may proceed with the
ancillary study as soon as it has been approved by the Executive Committee and
the Data Monitoring and Oversight Committee. If additional funds are needed,
the investigator may prepare and submit a new research grant application to the
potential sponsor for review in the same manner as any other new research grant
application. Copies of the grant application are sent to the Study Chairman, the
investigator is not to accept the grant or activate the ancillary study until
approval has been received from the CLEK Executive Committee.
16.9.7 Publication of Ancillary Study Results
All manuscripts of presentations for scientific meetings based on ancillary
study data must be reviewed and approved by the Executive Committee before
publication or presentation. Such review pertains only to the impact on CLEK
Study objectives, and not to the ancillary study’s scientific merit.
After publication, 35 reprints of the ancillary study report should be sent
to the Study Chairman’s Office for distribution to the Executive Committee, and
five copies should be sent to the Coordinating Center for the CLEK library.
16.9.8 Progress Reports
The Principal Investigator of each ancillary study is expected to report to
the Study Chairman at six-month intervals on the progress of the ancillary study.