Trial registration is required by many national and international guidelines and laws and is required by many journals

Clinical trial registration numbers should be included on all publications even if this is not required by the journal

Unregistered trials should be declared as such, and the reason for nonregistration provided

The agreement should commit authors and sponsors to work together to ensure that publications are complete, accurate, balanced, transparent, and produced in a responsible and timely manner

The agreement should describe the publication process including the role the sponsors will have in reviewing the publication (if any)

The agreement should describe what, if any, editorial and other support may be available for publication development

Sponsors should advise authors of any financial reporting requirements relevant to providing editorial and other support

The agreement should commit authors to take responsibility for the content, accuracy, and completeness of the publication

A publication steering committee may be formed to plan and oversee the development of publications

The committee should be formed before results are available

All investigators should be informed of the committee’s membership and its responsibilities

Membership of the steering committee does not automatically confer authorship

An authorship working group should be formed by the publication steering committee to ensure appropriate and transparent authorship decisions

The authors should work together to agree the order in which they will be listed

Authorship criteria should be applied consistently

All authors listed on a publication must fulfill the authorship criteria (i.e., there should be no guest authors)

All persons who fulfill the authorship criteria must be listed, including company-employed authors and contractors (i.e., there should be no ghost authors)

Authorship must represent a substantial intellectual contribution to both the research being reported and the development of the publication and a willingness to take public responsibility for these

Authorship must not be used as a reward or gift for services rendered

Authorship should be based on:

• substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data
• drafting or revising the work critically for important intellectual content
• final approval of the version to be published
• agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved

The author group should identify a corresponding author who will be responsible for communicating with the journal

One author should function as the primary contact between the journal and the other authors (= corresponding author)

The corresponding author does not need to be the lead author, but should be selected for their ability to help coordinate the review and revision process

The corresponding author takes primary responsibility for communication with the journal during submission, review, and publication

The corresponding author should be available to respond to editorial queries in a timely way

A primary publication is the first full report in a peer-reviewed journal of the primary outcomes of a study; secondary publications are additional reports of secondary or exploratory objectives, subgroup analyses, or post hoc analyses

Primary publications should be published before any secondary publications

Secondary publications should always reference the primary publication and be clearly identified as secondary publications

One or more authors of the primary publication of a study should contribute to any secondary publications to ensure appropriate understanding and interpretation of the original study

The primary article should always be accepted for publication before other articles reporting secondary endpoints

Secondary analyses should cite any primary publication and clearly state that they contain secondary analyses

Sponsors and authors should avoid redundant publication

Specific findings from a particular study should not be published in more than one journal unless they are reanalyzed or translated, the primary publication is clearly acknowledged, permission is obtained from the publishers, and copyright laws are upheld

Reuse of material from the authors’ previous publications should generally be avoided but exceptions may include descriptions of methods or data sources

Secondary publications should avoid redundancy and unjustified splitting of study findings across several publications

Editors of different journals may agree to publish the same article jointly if they consider this is in the best interest of public health, such publications should include a statement making this clear to readers

The design and results of all clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner

Publications should follow established reporting standards for specific study types (e.g., those found on the EQUATOR Network)

Articles should be considered for publication in the scientific literature regardless of whether the results are positive or negative

The article should follow established reporting guidelines (e.g., CONSORT, PRISMA, STROBE etc.)

Results should be submitted for publication within 18 months of the study end (for licensed products) or the date of licensing/discontinuation (for investigational products)

Ensure that all meaningful contributions to the research and publication by individuals and organizations are acknowledged

Each person named in the Acknowledgments should review the wording and provide written permission to be included

Those persons who are acknowledged must provide their written permission

The precise role and affiliations of professional medical writers must be disclosed

Vague acknowledgment of a professional medical writer’s role (e.g., for providing ‘editorial assistance’) must be avoided

Authors and sponsors should disclose all sources of funding and other types of support for the study

If a medical writer helps to develop a publication, the authors should disclose the writer’s name, professional qualifications, affiliation, and funding source

The role (if any) of the sponsor in the research and publication should always be clearly disclosed (e.g., involvement in study design, data collection or analysis, writing support, manuscript review)

Any involvement by persons or organizations with an interest in the findings (financial or nonfinancial) should be disclosed

Authors should declare whether they had access to the study data

All reviewer and editor comments should be addressed before the article is re-submitted

The journal editor should be advised if it is not possible to meet the original deadline for responding to reviewers’ comments (e.g., if extra analysis is required)

The corresponding author should act as a point of contact between the journal and the other authors and should keep co-authors informed and involve them in decisions about the publication (e.g., responding to reviewers’ comments)

Authors should approve the version to be published