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

2/22/96 Study Organization page 16-11
If the focus of the paper changes as it moves from abstract to the
manuscript stage, the primary author will notify the Study Chairman in writing.
The Study Chairman will be responsible for insuring that the revised proposal
receives appropriate review.
Each publication must acknowledge National Eye Institute support as
follows: “This study was supported by grants from the National Eye Institute,
National Institutes of Health, Bethesda, MD.”
Copies of principal papers from CLEK are sent (before publication) to all
Participating Clinic Principal Investigators, to all members of the Executive
Committee, and to the Data Monitoring and Oversight Committee. Reprints of
published papers are mailed to each Participating Clinic for distribution among
the staff and to outside consultants. Five reprints of each paper are sent to the
Coordinating Center for the CLEK library.
The Study Chairman will send a letter of approval with all manuscripts
when they are submitted for publication. Some journals require that all
individuals listed as members of the study group sign the copyright waiver form.
If so, the writing committee will enlist the assistance of the Study Chairman’s
Office to obtain these signatures.
All major study publications and presentations must receive approval of
the Data Monitoring and Oversight Committee prior to submission to any
professional journal or presentation at a meeting.
16.8.2 Presentations
Oral presentations and abstracts to be printed must be approved in
advance by the Executive Committee. No unpublished CLEK Study results may
be used for oral presentations, local or otherwise, unless a specific exception is
granted by the Executive Committee and the Data Monitoring and Oversight
Committee. Study results include all data collected for the CLEK Study. The
above restrictions do not apply to local presentations of the design of the Study,
provided these presentations contain no unpublished Study results. Such
presentations are encouraged to stimulate patient recruitment.
16.8.3 Publications from Ancillary Studies
Manuscripts dealing with ancillary studies carried out in conjunction with
the CLEK Study must be sent to the Executive Committee for review before