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DOWNLOAD DOCUMENT: CRA publication policy

1. Establishment of Authorship document for a CRA Pilot trial

1.1. Prior to the commencement of a study, the PI and the steering committee of the trial will agree on and circulate a document to all participating sites outlining the contribution criteria to qualify for authorship of the trial (e.g. number of included subjects or percentage of all recruited subjects).
1.2. This document may need to be updated if the pilot trial is funded as a “full trial” by CCFA, NIH or other institutions.

2. First Authorship

2.1. The PI of the Study is responsible for the oversight and the publication of the trial. Therefore, he is the first author of the publication.

2.1.1. If the PI designates another member of the study to compile (write) the study publication, this member may be first author and the PI either last author or second author.

2.1.2. First and second author can be listed as “equally contributed”, if e.g. a trial has 2 organizing investigators at a site.

3. Senior Authorship

3.1. The senior author could be a member of the steering committee of the trial or a collaborator in the study who significantly contributed to the conduct of the study.

4. Co-Authorship

4.1. Co-authors should have substantial contributions either to conception and study design or acquisition of study subjects or data or technology and material support or analysis and interpretation of data.

4.1.1. For qualification as Co-author due to acquisition of study subjects a certain number or percentage of all contributed study subjects to the trial should be defined before the start of the trial.

4.2. The CRA strongly advises a steering committee overseeing the trial, who advises the PI throughout the trial. The members of the steering committee should be co-authors of the trial. (Exemption: if one of the members was absent > 50% of the Steering sessions this member may not be included in the author list).

5. Authorship of participating sites

5.1. PI’s of sites, not fulfilling qualification criteria for Co-authorship as defined in 4.1 or 4.1.1., but with a contribution of at least 1 study subject to the trial should be listed in an appendix of the publication, and as collaborators for the purposes of listing as collaborators in PubMed, as in .