CMPP flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

GPP2022 core principle

Good Publication Practice guidance holds that publications should be complete, timely, and transparent, covering all findings including negative results, with disclosed contributions and funding.

ICMJE authorship criteria

Four criteria must all be met: substantial contribution, drafting or critical revision, final approval of the version published, and agreement to be accountable for the work.

Ghost authorship

Omission from the author list of a contributor who meets authorship criteria, often a professional writer or junior researcher, which breaches transparency standards.

Gift authorship

Listing an individual as an author who does not meet authorship criteria, for example a senior figure added for prestige or a manager who did not contribute.

Trial registration requirement

Interventional trials must be registered in a public registry before first participant enrolment, and results disclosed in the registry, to meet transparency expectations.

Professional medical writer disclosure

Writers who meet authorship criteria are listed as authors; otherwise they are named in acknowledgements with the source of their funding disclosed.

Sponsor review limits

Company review may check accuracy and confidentiality but must not change data, interpretation, or conclusions; the process and its limits are documented in advance.

Selective outcome reporting

Reporting only favourable prespecified outcomes while omitting others is a transparency breach; all primary and key secondary outcomes must be reported.

Publication plan gap analysis

A comparison of the target product profile and competitor evidence against planned disclosures, used to identify and prioritise missing evidence outputs.

Congress-to-manuscript sequencing

Abstracts are interim disclosures; each dataset presented at a congress should be followed by a full peer-reviewed manuscript reporting the complete results.

Publication Steering Committee

A governance body that approves the publication plan, oversees delivery, and resolves prioritisation conflicts, operating under a documented charter with defined membership.

Target journal selection criteria

Scope fit, audience reach, open access model, impact metrics, and time to publication, documented with rationale and revisited as data mature.

Plain-language summary planning

Lay summaries for patients and the public are planned alongside scientific manuscripts at the strategy stage rather than added after journal acceptance.

Publication timeline anchor

Manuscript scheduling is anchored to data lock and analysis plan finalisation, not to commercial milestones, because credible submission requires locked results.

Manuscript development sequence

Outline, first draft, internal review, author approval, journal formatting, submission, and response to decision, each with a named owner and date.

Version control for drafts

Every draft carries a version number and change log, and co-author approvals are captured in writing against the specific version submitted.

Reporting guideline by design

CONSORT for randomised trials, STROBE for observational studies, PRISMA for systematic reviews, and CARE for case reports guide manuscript structure and checklists.

Submission package contents

Cover letter, manuscript, figures, supplements, reporting checklist, author contributions, competing interests, and ethics or registration details are typically required.

Point-by-point reviewer response

A document addressing each reviewer comment with the change made and its location, agreed with authors and version-controlled alongside the revised manuscript.

Proof stage limits

Proofs are for checking typesetting accuracy; substantive changes to data or conclusions require editorial agreement and are documented.

Erratum versus retraction

An erratum corrects a publisher-introduced error; a retraction withdraws unreliable findings or addresses misconduct, with notices linked to the original record.

Preprint disclosure

Preprints and congress abstracts are prior dissemination and must be disclosed at journal submission according to the journal's preprint policy.

Publication steering committee charter

A document defining the committee's scope, membership, decision rights, meeting cadence, quorum, and conflict-of-interest management arrangements.

RACI responsibility matrix

A matrix naming who is responsible, accountable, consulted, and informed for each publication task across sponsor, authors, writers, and agencies.

Publication SOP audit trail

Standard operating procedures for development, review, and approval create records that allow any published claim to be traced to its evidence.

Escalation for ethical concerns

A documented route, independent of the commercial team, for raising concerns such as undisclosed authorship or data discrepancies.

Records retention for publications

Drafts, approvals, correspondence, and submission records are kept per organisational and regulatory schedules to support audit and inspection.

AI tool authorship rule

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

Data availability statement accuracy

Statements about data sharing must reflect what can actually be shared under participant consent and privacy law, and must not overpromise access.

Salami slicing

Splitting one dataset into multiple small publications without justification is misconduct; related manuscripts must be disclosed to editors at submission.

Publication KPI definition

Metrics such as planned versus actual submissions, acceptance rate, and time from data lock to submission, defined in advance with reproducible data sources.

Agency oversight acceptance criteria

Contracts with medical writing agencies define deliverables, quality checks, ownership of outputs, confidentiality, and disclosure obligations for writers.