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

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2/22/96 Study Organization page 16-9 16.7 Publicity All publicity and press releases for the CLEK Study are to have prior approval of the Executive Committee. Study investigators who are approached by the press for information concerning the Study should refer these inquiries to the CLEK Executive Committee. It is recognized that when information is sought from an individual investigator by the local press in his own community, it is sometimes necessary or desirable for the investigator to handle the request him/herself. In such an event the participating investigator should speak as an individual and not as the official representative of the CLEK Study Group. This fact should be made clear to the press; however, the information given out should be accurate and should reflect the general policy and views of the group. The Study Chairman should be informed of all local presentations to the press and be sent a copy of the material published. 16.8 Editorial Policy 16.8.1 Publication of Study Design, Methods, and Findings The Executive Committee will review all written reports prepared for publication. All reports from the CLEK Study will list the Collaborative Evaluation of Keratoconus (CLEK) Study Group as the last author. The primary endpoint paper and selected other major papers will list only the CLEK Study Group as the primary author in a manner consistent with the publication policy of the selected journal. Other publications will list the primary author and coauthors and the CLEK Study Group. All professional participants of CLEK, including those at the central units and Participating Clinics, will be listed at the end of each paper and are considered as authors or contributors. In major papers, all study personnel, past and present, will be listed with the approval of the Clinic Principal Investigator for whom they have worked. Conflicts regarding authorship are resolved by the Executive Committee. General guidelines for authorship are: active participation in the production of the manuscript or other important contribution. Authorship rights are not available for membership on the writing committee only, use of data only, or signing the copyright form. If the timeline for a paper has expired with no substantial evidence of progress, authorship rights are assumed to have expired. The Coordinating Center will contact the primary author, and leadership of the paper will be negotiated. The Executive Committee will be informed of changes in lead authorship. An individual may be given an acknowledgment for reading and providing critical comments on the manuscript. An investigator at the
2/22/96 Study Organization page 16-10 Coordinating Center will be added to the author list on all papers which require his or her statistical input. The Executive Committee establishes writing committees for principal papers from among the CLEK investigators. Investigators may volunteer for writing assignments and suggest additional topics where appropriate. A representative of the Coordinating Center will be appointed to writing committees on papers or presentations requiring study data. Investigators may volunteer for writing assignments and suggest additional topics where appropriate. The investigator should submit an abstract and a short description of the proposed paper including co-authors, data to be reported and timeline for drafts and submission (Appendix 16A). This information should be sent to the Study Chairman. The Executive Committee is responsible for reviewing the proposal’s merit and deciding if it should be an CLEK Study publication. This review process is intended to insure the quality of study publications and to refine the proposal. The Executive Committee is responsible for determining priorities (timeline and order of preparation) of proposed papers/presentations. Upon approval of the proposed paper/presentation, a detailed analysis plan and timetable are developed with the Coordinating Center. The Coordinating Center is responsible for maintaining a database that tracks proposed and approved study publications and presentations. A list of approved study publications and presentations will be distributed to all CLEK investigators on a regular basis. Interested CLEK investigators are invited to contact the primary author to add their name to the writing group. Should the workload associated with the preparation of papers exceed the resources of the Coordinating Center, it will be the responsibility of the Coordinating Center in conjunction with the Executive Committee to establish priorities. It will be the responsibility of the Coordinating Center to contact primary authors when timelines are not met. Major problems in the preparation of manuscripts are referred to the Executive Committee. The primary author is responsible for coordinating all activities related to the writing and submission of papers and abstracts. This includes arranging conference calls, discussing analytic plans with the Coordinating Center, assigning writing responsibilities to co-authors, maintaining timeliness, determining the order of authorship, circulating drafts to co-authors, and circulating final drafts to the Executive Committee and as needed, to the Data Monitoring and Oversight Committee. Upon circulation of the draft, there will be a two-week period during which members can make comments about the paper.
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OM t of c.iii - Vision Research Coordinating Center - Washington ...

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