Publication Governance and SOPs
Pubrica develops publication policies and standard operating procedures (SOPs) and supports publication steering committees for sponsors of company-sponsored research and their publication teams. GPP 2022 expects a steering committee with clear decision rights, a documented policy on authorship and disclosure, and a record of how decisions were made. Our publication governance specialists write an SOP your team can follow in practice, operationalise ICMJE authorship criteria, and set up and facilitate your steering committee.
- A concise, practical SOP covering decision points, owners and escalation routes rather than restating GPP 2022
- Operationalised authorship criteria that define who decides, on what evidence, and how disputes are resolved
- Steering committee terms of reference, with a standing agenda and minutes that record the reasoning behind each decision
- Procedures for difficult cases, including an unpublished negative study, a departing author and an investigator who wants to publish independently
- Auditable decision records that demonstrate your policy was applied in practice
SOP and policy writtenIncluded
Authorship process operationalisedIncluded
Steering committee set up and runIncluded
Decision records maintainedIncluded
Making decisions on your behalfExcluded; the committee decides
Policy → SOP → committee → decisions → record
- SOP written for practical use
- Authorship process with an owner
- Committee terms of reference
- Minutes that record reasoning
- Auditable decision trail
Deliverables
Four Components of Every Publication Governance Engagement
Each engagement delivers documents and records that show your publication policy is applied in practice, not only that it exists.
From the SOPA forty-page SOP that restates GPP 2022 is difficult to apply. Our SOPs set out decision points, owners and escalation routes so that teams can follow them.
From the authorship procedureAuthorship will be determined in accordance with ICMJE criteria.The lead author drafts a contribution table at protocol stage and updates it at analysis. The publication lead assesses it against the four criteria. Disputes go to the steering committee, whose decision is minuted with reasoning. Nobody is added at submission.
From the terms of referenceThis boundary is essential. A steering committee that decides scientific conclusions is acting outside the role that GPP 2022 sets for it.
From the procedureAgreeing the rule in advance, before anyone has a stake in the outcome, makes these cases much easier to resolve.
Samples are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Publication Governance Standards: GPP 2022, ICMJE and COPE
GPP 2022, ICMJE and COPE define good publication practice. Your SOP sets out how your organisation applies them.
GPP 2022 (good publication practice)
The 2022 update, replacing GPP3. It covers company-sponsored research, including translational, biomarker and real-world studies, and extends to preprints, plain language summaries and social media. Professional medical writing support is legitimate, provided it is disclosed.
ICMJE Recommendations (authorship and disclosure)
Four criteria, all of which an author must meet. Contributors who fall short are acknowledged. Employment by the sponsor neither qualifies nor disqualifies anyone.
COPE (Committee on Publication Ethics)
Guidance on authorship disputes, redundant publication, undisclosed conflicts of interest and corrections, which journals apply when an integrity concern is raised.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Certified quality management covering how each project is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in Publication Governance
Medical affairs work requires a clear distinction between scientific exchange and promotion, which regulators monitor. That judgement depends on context, jurisdiction and individual circumstances, so our specialists make it rather than an AI tool.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, as it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our Publication Governance Process Works
We begin by reviewing how publication decisions are currently made, which often differs from what the existing policy describes.
Review of current practice
We establish how publication decisions are made today, who makes them, and where practice has diverged from the existing policy.
Policy and SOP drafting
We write a short policy stating your principles and an SOP setting out decision points, owners, timelines and escalation routes.
Steering committee set-up
We prepare terms of reference, membership, a standing agenda and a minute format that records the reasoning behind decisions as well as the outcomes.
Facilitation and review
Where useful, we facilitate committee meetings and periodically check that the SOP is being followed in practice.
Our Experts
Your Publication Governance Team
Your project is handled by a named team of subject specialists who stay with it from scoping to delivery. Your project coordinator introduces each team member before work begins.
Reviews the scientific content for accuracy and confirms that each conclusion is supported by the evidence. Each expert is matched to your field of research.
Writes the content against the brief and the applicable code of practice, with every claim traceable to its reference.
Reviews the content for scientific accuracy, fair balance and compliance with the applicable code before it reaches your internal review.
Manages the timeline, keeps you informed at each stage and coordinates the team so that questions are answered and deadlines are met.
Packages
Publication Governance Packages
Each package is quoted by scope, based on organisation size, the number of programmes and whether governance is being established or repaired.
Policy and SOP drafting
Establishing governance
Quoted per projectBased on organisation size
Delivery By scope
- ✓Current practice reviewed
- ✓Policy written to GPP 2022
- ✓SOP with decision points and owners
- ✓Authorship procedure operationalised
- ✓Procedures for difficult cases
- ✓Training materials for the team
SOPs are written for practical use and kept as concise as possible.
Deliverables Request a quoteSteering committee
Set-up or ongoing support
Quoted per projectBased on meeting frequency
Delivery Ongoing
- ✓Terms of reference drafted
- ✓Membership and decision rights defined
- ✓Standing agenda and papers
- ✓Facilitation and minuting
- ✓Decision record maintained
- ✓Action tracking between meetings
We facilitate meetings and keep the record. The committee makes the decisions, and the minutes document that it did.
Deliverables Request a quoteGovernance audit
Review of existing governance
Quoted per projectBased on programme count
Delivery By scope
- ✓SOP tested against actual practice
- ✓Authorship decisions sampled
- ✓Disclosure practice checked on published papers
- ✓Unpublished studies identified
- ✓Findings reported by severity
Sampling published papers against your SOP is the test an external auditor would apply, and running it internally first lets you address any findings.
Deliverables Request a quoteSend us your current publication SOP and we will test it against three of your published papers at no cost, covering authorship, disclosure and writing acknowledgement.
FAQs
Frequently Asked Questions About Publication Governance
If your question is not answered here, please ask an expert. No quote is required.
The committee decides which outputs the programme will produce, in what sequence and to what timeline. It also resolves authorship disputes and questions of scope.
It does not decide scientific conclusions, which remain the responsibility of the authors. This boundary separates governance from interference and should be stated in the terms of reference.
GPP 2022 tells you what good practice looks like. It does not tell your organisation who decides authorship, by when, or what happens on a dispute.
The SOP turns the guideline into a procedure that a specific team can follow and an auditor can test.
That should be covered by the clinical trial agreement and reflected in the SOP, with a notice period and a review window rather than a veto.
A sponsor that tries to block investigator publication creates a more serious problem than the one it aims to avoid, so the procedure should assume that publication will go ahead.
You show it through contribution records, minuted authorship decisions with reasoning, and disclosure statements on published papers that match the SOP requirements.
A policy without a decision trail cannot be distinguished from having no policy, which is why the minute format matters as much as the SOP.
Related services
Related Publication and Communication Services
Publication governance oversees the planning, writing and review of your publications. These related services support that work.
1PROGRAMME SERVICESplanning and writing
Publication planningPublication plans for committee approval. Scientific writingManuscript writing for the programme.2INTEGRITY AND REVIEWintegrity
Research integrity casesCase handling in line with COPE guidance. Pre-submission peer reviewExpert review before journal submission.3MEDICAL AFFAIRSstrategy and platform
Medical affairs strategyStrategy for the medical affairs function. Scientific platformThe core scientific statements of the programme.Request a Free Review of Your Publication SOP
We review authorship, disclosure and writing acknowledgement, the same three areas an external auditor would check.