CMPP cheat sheet

Publication planning starts from the evidence base: map every completed, ongoing, and planned study to its expected data-readout date, then derive a publication timeline from those dates rather than from marketing calendars.

A publication plan gap analysis compares the target product profile and competitor evidence landscape against planned disclosures; unresolved evidence gaps become new study or analysis proposals, not suppressed findings.

Authorship and contributor roles are agreed at the planning stage using ICMJE criteria and, where relevant, CRediT taxonomy; contributors who do not meet authorship criteria are acknowledged with permission.

Congress-to-manuscript sequencing rule: abstracts presented at congresses should be followed by full peer-reviewed manuscripts; the abstract is a placeholder, not the terminal disclosure of a dataset.

Target journal selection considers scope fit, audience reach, open access model, impact metrics, and time to publication; journal choice is documented with rationale and revisited as data mature.

Publication Steering Committee or equivalent governance body approves the plan, oversees delivery, and resolves prioritisation conflicts; its membership, remit, and quorum are documented in a charter.

Patient and public involvement, plain-language summaries, and lay dissemination routes are planned alongside scientific manuscripts, not added after acceptance.

Timeline risk is managed by tracking registration status, statistical analysis plan finalisation, and data lock; a manuscript cannot credibly be scheduled before the analysis is locked.

Plan metrics include planned versus actual submissions, acceptance rates, median time from data lock to submission, and open access compliance; these are reviewed at defined intervals.

Publication development follows a documented sequence: outline, first draft, internal review rounds, external author approval, journal formatting, submission, and post-decision response; each stage has an owner and a date.

Every draft version is controlled with version numbers and a change log; co-author approvals are captured in writing for the specific version submitted.

Good publication practice requires that a qualified professional writer's contribution be disclosed in the manuscript acknowledgements, together with the funding source for that support.

Journal selection is executed against author instructions: word limits, reference caps, figure counts, reporting guideline checklists (CONSORT, PRISMA, STROBE as applicable), and data-sharing statements.

Submission packages typically include cover letter, manuscript file, figures, supplementary material, reporting checklist, author contribution statement, competing interest declarations, and ethics/registration details.

Peer-review responses are point-by-point, evidence-based, and agreed with authors; the response document and revised manuscript are version-controlled together.

Proof stage is limited to checking typesetting accuracy; substantive changes to data or conclusions at proof require editorial agreement and are documented.

Post-publication obligations include correcting errors via erratum or corrigendum, and retracting when findings are unreliable; corrections are linked to the original record.

Dissemination tracking records congress presentations, manuscript publications, and plain-language outputs against the plan, with deviations logged and explained.

GPP2022 (Good Publication Practice) sets the expectation that publication is complete, timely, and transparent: all findings, including negative and null results, are disseminated.

ICMJE authorship requires all four criteria: substantial contribution, drafting or critical revision, final approval of the version to be published, and agreement to be accountable for the work.

Ghost authorship is the omission of a contributor who meets authorship criteria; gift authorship is the inclusion of someone who does not; both are prohibited.

Trial registration in a public registry before first participant enrolment, and disclosure of results in the registry, are baseline transparency requirements for interventional studies.

Financial and non-financial competing interests of all authors and contributors are declared, including employment, consultancy, honoraria, and writing support.

Professional medical writers must be named in acknowledgements, and their funding source disclosed; they must not be listed as authors solely for writing support unless they meet authorship criteria.

Sponsor and company review of manuscripts is permitted for accuracy and confidentiality, but must not alter data, interpretation, or conclusions; the review process and its limits are documented in advance.

Data integrity expectations cover retention of source data, reproducibility of analyses, and availability of a statistical analysis plan; data-sharing statements must reflect what can actually be shared.

Duplicate or redundant publication, salami slicing, and undisclosed secondary analyses are misconduct; prior presentation as an abstract must be disclosed at submission.

A publication steering committee charter defines scope, membership, decision rights, meeting cadence, quorum, and conflict-of-interest management for the group.

Role clarity across sponsor, authors, medical writers, and agencies is documented in a responsibility matrix (for example RACI) that names who approves, who drafts, and who is informed.

Standard operating procedures for publication development, review, and approval create an auditable trail; deviations are recorded with rationale.

Author agreements, confidentiality terms, and disclosure of writing support are captured in contracts or letters of agreement before drafting begins.

Collaboration with external authors requires early alignment on data access, analysis interpretation, and publication timing, with a documented dispute-resolution route if consensus fails.

Publication records, drafts, approvals, and correspondence are retained per organisational and regulatory retention schedules so that any published claim can be traced to evidence.

Training and competence records for staff involved in publication delivery support compliance evidence during audits and inspections.

Governance escalation paths define who decides when sponsor and authors disagree on interpretation, and how unresolved disagreements are disclosed.

Landscape mapping catalogues competitor publications, congress data, and guideline positions to identify where the product's evidence adds distinct value.

Evidence gap prioritisation ranks gaps by clinical relevance, data availability, and stakeholder need; ranking drives resource allocation across manuscripts.

A publication plan is a living document reviewed at defined intervals (for example quarterly) and on trigger events such as data lock, trial termination, or new competitor data.

Core data sheet and label claims are cross-checked against planned publications so that promotional and scientific communications remain consistent with approved evidence.

Authorship planning assigns lead and senior author roles per manuscript based on data contribution and expertise, documented before drafting begins.

Congress abstract deadlines are fixed external constraints; the plan works backwards from those deadlines to internal approval dates.

Publication of trial results should occur within a defined interval after study completion; timelines slipping beyond that interval require documented justification and escalation.

Stakeholder mapping identifies payers, regulators, health technology assessment bodies, clinicians, and patients, and matches each to appropriate dissemination formats.

Statistical outputs are locked before manuscript drafting; any post hoc analysis is labelled as such and its rationale stated.

Author approval rounds are time-boxed, and non-response is escalated per the documented process rather than assumed as consent.

Figures and tables are checked against source outputs, and the underlying data are traceable to the analysis dataset used.

Reporting guideline selection is driven by study design: CONSORT for randomised trials, STROBE for observational studies, PRISMA for systematic reviews, CARE for case reports.

Cover letters state the novelty, fit with journal scope, prior presentation of the data, and any related manuscripts under consideration elsewhere.

Journal decision outcomes are handled systematically: accept, minor revision, major revision, reject with resubmission offer, or reject; each triggers a defined next action.

Resubmission to a different journal requires reformatting, rechecking reporting requirements, and confirming all authors approve the new target.

Publication of record is the version of record; preprints and congress abstracts are disclosed as prior dissemination and are not treated as the citable final report.

GPP2022 emphasises that everyone who meets authorship criteria is listed, and anyone who contributed but does not meet criteria is acknowledged with consent.

AI tools cannot be listed as authors; their use in drafting or analysis is disclosed in methods or acknowledgements, and authors remain accountable for content.

Plagiarism checks, including self-plagiarism and text recycling, are performed before submission, with journal text-recycling policies checked.

Patient privacy requires that identifying information be removed and informed consent for publication obtained where individual details are reported.

Research ethics approval, informed consent, and trial registration numbers are stated in the manuscript; absence of any of these must be explained.

Sponsor review must be disclosed where journals require it, and the manuscript must state that the sponsor did not control the decision to publish.

Retraction is reserved for unreliable findings or misconduct; expressions of concern may be issued while an investigation is ongoing.

Authorship changes after submission require journal notification and signed agreement from all authors, including the person added or removed.

Meeting minutes for publication steering committees record decisions, actions, owners, and dates, and are retained as governance evidence.

Conflict-of-interest declarations are collected and refreshed at defined intervals and before each major publication milestone.

Agency and vendor oversight includes defined deliverables, quality checks, and acceptance criteria documented in the statement of work.

Audit readiness requires that each published manuscript can be linked to its protocol, analysis plan, approval records, and author agreements.

Key performance indicators for the publication function are defined in advance with data sources, so performance reporting is reproducible.

Escalation of ethical concerns (for example undisclosed authorship or data discrepancies) follows a documented route independent of the commercial team.

Succession and handover documentation protects continuity when publication leads or agency partners change during a long programme.

Publication strategy is aligned to the product lifecycle stage: pre-launch focuses on pivotal evidence, launch on data dissemination to prescribers, and post-launch on real-world and health economic evidence.

Health economics and outcomes research publications are planned with payer evidence needs in mind, including budget impact and cost-effectiveness models.

Real-world evidence publication plans specify data source, governance approvals, and prespecified analyses to reduce post hoc criticism.

Publication of negative or inconclusive results is planned at the outset, since selective reporting is a transparency failure and can distort the evidence base.

A publication plan includes a data-sharing and access plan for external researchers, consistent with sponsor policy and participant consent.

Cross-functional input is sought from clinical, regulatory, statistics, and medical affairs when prioritising manuscripts, with decisions recorded.

Journal and congress target lists are reviewed against acceptance history and audience fit to avoid repeated submission to poor-fit outlets.

Draft development begins with a detailed outline that fixes key messages, data displays, and target journal, reducing rework in later rounds.

Reference management uses a single shared library with verified citations; every cited claim is checked against the primary source.

Internal review comments are consolidated and adjudicated by the lead author, with resolution recorded rather than left implicit.

Journal submission systems require ORCID identifiers, corresponding author details, and all co-author email addresses for verification.

Post-acceptance tasks include licence agreements, open access payment or waiver requests, and proof correction within the journal's deadline.

Preprint posting is decided with all authors and disclosed at journal submission per the journal's preprint policy.

Publication metrics are captured at defined intervals after publication and reconciled with the plan to inform future strategy.

Selective reporting of favourable outcomes within a study is a transparency breach; the manuscript reports all prespecified primary and key secondary outcomes.

Protocol and statistical analysis plan amendments are disclosed with dates so that readers can judge whether analyses were prespecified.

Authors must be able to access the underlying data and must be accountable for the integrity of the work, per ICMJE accountability criteria.

Undisclosed ghostwriting support, including agency drafting without acknowledgement, is a serious breach and can warrant retraction.

Journal and sponsor policies on data availability must be consistent with participant consent and applicable privacy law; statements must not overpromise access.

Corrections must be transparent: the nature of the error, the corrected content, and the effect on conclusions are stated in the notice.

Editors must be informed of any known errors before or immediately after publication, rather than waiting for readers to detect them.

Publication governance interfaces with pharmacovigilance and regulatory affairs so that safety findings are disclosed consistently across channels.

Version control and document management systems provide the audit trail for drafts, approvals, and submissions across the programme.

Contracts with medical writing agencies specify ownership of outputs, confidentiality, and disclosure obligations for writers.

Disagreement between authors and sponsor on conclusions is resolved by evidence review; if unresolved, the disagreement may be disclosed per journal policy.

Training on GPP2022, ICMJE, and publication ethics is documented for authors, reviewers, and agency staff involved in delivery.

Periodic self-assessment against GPP2022 principles identifies gaps in process, documentation, and disclosure before external audit.

An environmental scan captures congress calendars, journal special issues, and guideline update cycles that create disclosure windows.

Publication priorities are ranked using explicit criteria such as data maturity, clinical impact, and stakeholder demand, and the ranking is recorded.

Budget planning covers writing support, open access fees, congress fees, and translation, and is linked to the publication timeline.

Plain-language summary production is planned for every study report to meet patient and public transparency expectations.

Plan reviews check that every registered study has a corresponding publication commitment, closing gaps between registration and disclosure.

Manuscript quality checks cover consistency of numbers between abstract, text, tables, and figures before submission.

Author contribution statements use a consistent taxonomy and match the recorded contributions in the project file.

Supplementary materials are checked for de-identification and consistency with the main text before upload.

Submission confirmations and manuscript identifiers are recorded in the publication tracker to maintain a complete audit trail.

Response to reviewers includes the location of each change in the revised manuscript to speed editorial assessment.

All authors must approve the final version submitted; approval by proxy or silence is not acceptable evidence of approval.

Acknowledgement of contributors requires their permission, and the nature of their contribution is stated specifically.

Funding sources for the study and for writing support are disclosed separately and precisely in the manuscript.

Any prior publication of the same data, including in another language, is disclosed to the editor at submission.

Authors must disclose relationships that could be perceived as influencing the work, not only those they judge material.

Publication committee decisions are minuted with rationale so that prioritisation can be defended in audits.

Cross-functional collaboration agreements define data access rights, review timelines, and sign-off authority for each function.

Vendor performance is reviewed against agreed quality and timeline metrics, with corrective actions documented.

Records retention schedules align with regulatory requirements and are applied consistently to electronic and paper files.

Ethics consultation is available to publication staff for authorship disputes and disclosure questions, with outcomes recorded.

Publication strategy documents the intended audience for each output and the channel that reaches that audience most effectively.

Competitive intelligence on competitor trial readouts informs timing decisions so that disclosures are not crowded out.

Guideline development cycles are monitored so that evidence can be submitted to guideline panels at the right time.

Publication plans include congress presentation formats (oral, poster, encore) and rules on encore presentation disclosure.

Strategy reviews consider whether the accumulated evidence supports a review article or meta-analysis to consolidate the dataset.

Statistical review of the manuscript confirms that reported estimates, confidence intervals, and p-values match the analysis outputs.

Figures are checked for axis labelling, units, and legibility at print size, and permissions are obtained for any adapted material.

Reference lists are checked for retracted articles before submission, since citing retracted work requires justification.

Submission portals require the corresponding author to confirm all co-authors have seen and approved the submission.

Post-publication promotion is limited to accurate representation of the published findings and does not extend beyond the data.

GPP2022 recommends that publication planning be documented and that the plan be available to those who need it for oversight.

Authorship criteria are applied consistently across a programme, not varied to suit individual manuscripts.

Company review of manuscripts must be completed within agreed timelines and must not delay publication indefinitely; delays are documented.

Any payment to authors or contributors that could constitute an inducement is prohibited; honoraria for genuine advisory work are disclosed.

Publication of data that could affect patient safety is not delayed for commercial reasons; safety disclosures follow regulatory obligations.

Publication steering committee membership includes clinical, statistics, regulatory, and medical affairs representation with defined deputies.

Documented decision logs record who approved each manuscript version and on what date.

Confidentiality agreements cover pre-publication data shared with agencies and external authors.

Audit findings are tracked to closure with owners, dates, and evidence of remediation.

Governance reviews assess whether publication activities complied with internal SOPs and external standards, with findings reported to senior management.

Publication strategy defines success measures such as reach, citation, guideline inclusion, and payer uptake, chosen before execution.

Evidence synthesis activities, including systematic reviews, are planned when the trial base is fragmented across sponsors.

Publication plans account for regulatory submission timelines, since some disclosures are constrained until approval.

Patient-reported outcome publications are planned separately where they address distinct stakeholder questions.

Plan documentation records the rationale for deferring or not pursuing a publication, so that omissions are explainable.

Manuscript templates and style guides standardise terminology, abbreviations, and units across a programme.

Data checks reconcile every number in the manuscript to the validated tables produced by statistics.

Author approval is recorded against the exact file version submitted, with the file hash or version number noted.

Journal queries during production are answered within the stated deadline to avoid publication delays.

Post-publication access is monitored, and requests for data or reprints are handled per the disclosed policy.

Guest and ghost authorship are both prohibited; every listed author must meet all four ICMJE criteria.

The corresponding author is responsible for communication with the journal and for confirming all authors' approvals.

Authors must disclose any use of professional medical writers, including the funding source for that support.

Manuscripts must report the role of the sponsor in design, analysis, interpretation, and the decision to publish.

Editors must be told of any related manuscript under consideration or published elsewhere, including in another language.

Publication team roles and responsibilities are documented so that handovers do not lose approval records.

Governance includes periodic review of the publication plan against actual delivery, with variances explained.

Escalation routes for authorship disputes are defined and independent of commercial pressures.

Training records for publication ethics and GPP2022 are maintained for all staff and agency partners involved.

External audits are supported by organised evidence packs containing plans, approvals, drafts, and correspondence.

Publication planning begins with a review of the target product profile and the evidence required to support each claim.

Stakeholder needs are mapped to evidence outputs, so that each audience receives material relevant to its decisions.

The plan records which studies will not be published and why, providing an audit trail for omissions.

Congress and journal targets are reviewed against previous acceptance and audience fit before commitment.

Publication timelines include buffer for author review and journal processing, since these are common delay points.

Drafting starts from a fixed outline with agreed key messages and data displays to limit later rework.

All co-authors receive the same version with tracked changes, and comments are consolidated by the lead author.

Reporting checklists are completed and uploaded with the submission where the journal requires them.

Submission receipts and manuscript numbers are filed in the publication tracker for audit purposes.

Post-acceptance tasks include licence signing, open access arrangements, and proof correction within deadline.

All prespecified outcomes are reported, including those that were not statistically significant.

Protocol amendments and analysis plan changes are disclosed with dates in the manuscript.

Data availability statements must be accurate and consistent with consent and privacy law.

Corrections state the error, the correction, and the effect on conclusions.

Errors known before publication are disclosed to the editor immediately rather than left for readers to find.

Publication SOPs define the required review rounds, approvers, and records for each manuscript.

Deviation from SOP is documented with rationale and approved by the responsible governance body.

Contracts with agencies specify deliverable ownership, confidentiality, and disclosure of writer contributions.

Publication records are retained per schedule so that any published claim is traceable to its evidence.

Periodic self-assessment against GPP2022 identifies process gaps before external audit.

An environmental scan tracks congress calendars, journal special issues, and guideline cycles that create disclosure windows.

Publication priorities use explicit criteria such as data maturity, clinical impact, and stakeholder demand, and are recorded.

Budget planning covers writing support, open access fees, congress fees, and translation, linked to the timeline.

Plain-language summaries are planned for every study report to meet transparency expectations.

Plan reviews confirm every registered study has a publication commitment, closing registration-to-disclosure gaps.

Numbers are checked for consistency across abstract, text, tables, and figures before submission.

Author contribution statements use a consistent taxonomy and match recorded contributions.

Supplementary files are checked for de-identification and consistency with the main text.

Submission confirmations and manuscript identifiers are recorded to maintain a complete audit trail.

Reviewer responses cite the location of each change to speed editorial assessment.

All authors approve the final submitted version; silence or proxy approval is not acceptable.

Acknowledged contributors give permission, and their contribution is described specifically.

Study funding and writing support funding are disclosed separately and precisely.

Prior publication of the same data, including in another language, is disclosed at submission.

Relationships that could be perceived as influencing the work are disclosed, not only those judged material.

Committee decisions are minuted with rationale so prioritisation can be defended in audits.

Collaboration agreements define data access, review timelines, and sign-off authority per function.

Vendor performance is reviewed against quality and timeline metrics, with corrective actions documented.

Retention schedules apply consistently to electronic and paper publication records.

Ethics consultation is available for authorship and disclosure questions, with outcomes recorded.

Strategy documents the audience for each output and the channel that reaches it most effectively.

Competitive intelligence on trial readouts informs timing so disclosures are not crowded out.

Guideline cycles are monitored so evidence reaches panels at the right time.

Congress formats (oral, poster, encore) and encore disclosure rules are specified in the plan.

Strategy reviews consider whether accumulated evidence supports a review or meta-analysis.

Statistical review confirms estimates, confidence intervals, and p-values match analysis outputs.

Figures are checked for axis labelling, units, and print legibility; permissions are obtained for adapted material.

Reference lists are checked for retracted articles, and citing retracted work requires justification.

The corresponding author confirms all co-authors have seen and approved the submission.

Post-publication promotion is limited to accurate representation of published findings.

Publication planning is documented, and the plan is available to those with oversight responsibility.

Authorship criteria are applied consistently across a programme, not varied per manuscript.

Company review must not delay publication indefinitely; delays are documented with reasons.

Payments that could act as inducements are prohibited; honoraria for genuine advisory work are disclosed.

Safety-relevant data are not withheld for commercial reasons; disclosure follows regulatory obligations.

Steering committee membership includes clinical, statistics, regulatory, and medical affairs representation with deputies.

Decision logs record who approved each manuscript version and when.

Confidentiality agreements cover pre-publication data shared with agencies and external authors.

Audit findings are tracked to closure with owners, dates, and remediation evidence.

Governance reviews assess compliance with internal SOPs and external standards, reporting to senior management.

Success measures such as reach, citation, guideline inclusion, and payer uptake are chosen before execution.

Systematic reviews are planned when the trial base is fragmented across sponsors.

Publication plans account for regulatory submission timelines that constrain disclosure.

Patient-reported outcome publications are planned separately where they answer distinct stakeholder questions.

Deferrals and non-publication decisions are documented with rationale so omissions are explainable.