Good Publication Practice 2022 Overview

Questions and Answers

What is a primary reason for forming a Publication Steering Committee?

To conduct peer reviews of other journals

To determine copyright licenses for published works

To approve final publication designs

To outline roles and responsibilities before data availability (correct)

When does the Publication Steering Committee first meet?

At the start for initial planning of publications (correct)

Upon receiving the final data results

When authorship decisions need to be made

After the first draft of the study is completed

What should happen to the roles regarding publication and presentations?

Roles should be agreed upon before any data is available (correct)

Roles should be decided post-publication

Roles should be assigned randomly

Roles should be kept confidential from stakeholders

What is the purpose of ensuring appropriate and transparent authorship decisions?

To establish clear accountability and credibility in the publication process Signup and view all the answers

How often does the committee meet after the initial planning session?

Annually, as data becomes available for updates Signup and view all the answers

What specific information is provided to study investigators regarding the committee?

Information on committee membership and responsibilities Signup and view all the answers

What is the outcome when the writing and review process is complete?

The committee is permanently disbanded Signup and view all the answers

What is the necessity of establishing a charter or guidance document?

To guide the committee's future meetings and roles Signup and view all the answers

Before the Publication Steering Committee is formed, which stakeholders are typically involved?

Both internal and external stakeholders, including a chair Signup and view all the answers

What key factor is to be monitored during data availability?

Updates to the publication and presentation plan Signup and view all the answers

Study Notes

Publication Plans Principles

Auditable publication plans adhere to Good Publication Practice (GPP) and sponsor policies.
All relevant clinical trial data, including regional studies, must be included in the publication plan.
Priority is given to primary publications detailing prespecified primary endpoints over secondary publications and reviews.
Background information, including new methods and techniques, should be published prior to clinical data.

Budgeting and Scientific Needs

All components of publications, such as plain language summaries and enhanced content, must be factored into planning and budgeting.
Identification of scientific and clinical needs is essential for secondary analyses, pooled data analyses, or systematic reviews.

Journal Selection and Access

Selection of journals and conferences must be appropriate; timelines should align with data availability.
Prioritize open-access and free-to-access publication options.

Publication Integrity and Author Responsibilities

Encore publications and translations should meet scientific needs or reach audiences with limited access to the original work.
Authors must be informed of their roles and responsibilities promptly, with relevant working groups established for publication development.
Authors should have access to relevant study data, ensuring consistency across various publication formats.

Embargo and Communication Policies

Respect embargoes set by journals or conferences; improper communication about trials must be avoided.
Social media and press releases are to be handled by designated individuals and groups to uphold embargoes.

Feasibility and Timing

Publication planning must consider the timing capabilities of authors and contributors, especially when multiple publications are in progress.
Ample time should be allocated for proofreading, data verification, and quality assurance.

Preprint Considerations

Preprints can refine research questions and analyses; they may also be indexed and assigned DOIs.
Journal policies fluctuate regarding preprints; some recognize them as prior publications, while others do not allow citations from them.

Publication Steering Committee Lifecycle

Formation of a publication steering committee is initiated by sponsors or publication professionals before data availability, involving both internal and external stakeholders.
Responsibilities are defined through a charter or guidance document before meetings commence for planning presentations and publications.
Regular updates are conducted as data becomes available and publication roles are agreed upon to ensure transparency in authorship decisions.

Description

This quiz covers the principles for developing auditable publication plans in compliance with Good Publication Practice (GPP) and sponsor policies. It emphasizes the importance of reflecting all clinical trial data and pertinent research in publication efforts. Test your understanding of these essential publication guidelines.