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Table 3 Five-Step Authorship Framework to Improve Transparency in Disclosing Contributors to Industry-sponsored Clinical Trial Publications

From: Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications

Step

Tasks

1

Establish an authorship working group of core trial contributors as close as possible to trial commencement but prior to enrollment of first patient. For smaller trials where an authorship working group is not feasible, this committee may be a sub-committee of a larger Trial Steering Committee where one exists.

2

Determine, in the context of the ICMJE authorship criteria and the specific trial, which authorship contributions will qualify as `substantial’ and include these details in written publication agreements for all trial contributors.

3

Implement a process to track and document in a concise format progress toward substantial contributions based on agreed-upon qualifications.

4

Assess documented trial contributions for the specific study and invite those making a `substantial contribution’ to participate as author(s).

5

Ensure invited authors meet remaining ICMJE authorship criteria during content development and publication submission.