Purpose and Scope
This policy establishes publisher-level expectations for manuscripts reporting clinical trials and related interventional research. Journals may define discipline-specific registration, reporting, protocol, and data-sharing requirements consistent with this framework.
Authors remain responsible for compliance with applicable law, regulation, ethics approval, registry requirements, funder obligations, and the journal’s instructions.
Definition and Journal Applicability
For publication purposes, journals should define the types of prospective health-related interventions and outcome assignments that fall within their clinical-trial requirements. Borderline designs should be assessed according to the nature of the intervention and prospective assignment rather than the label used by authors.
Journal instructions should state whether additional categories of interventional or feasibility research are subject to the same registration rules.
Prospective Registration
Trials subject to registration requirements should be registered in an appropriate publicly accessible registry within the timeframe required by the journal and applicable standards. For journals applying ICMJE clinical-trial requirements, registration is expected at or before enrollment of the first participant.
Late registration should be disclosed and explained. Registration after study completion should not be presented as prospective registration.
Registry Record and Manuscript Consistency
The manuscript should provide the trial registration identifier and should be reasonably consistent with the registered protocol information, including primary outcomes, key secondary outcomes, enrollment, interventions, and analysis plans.
Material discrepancies should be explained. Editors may compare submitted manuscripts with registry history rather than relying only on the current registry entry.
Ethics Approval and Consent
Clinical trials must have appropriate prospective ethical oversight and informed-consent processes unless a lawful and ethically justified waiver applies. Manuscripts should report the relevant ethics committee and approval information as required by the journal.
Registration does not substitute for ethics approval, and ethics approval does not substitute for registration when both are required.
Protocols, Statistical Plans and Reporting
Authors should report trials according to appropriate reporting standards and provide protocol or statistical-analysis-plan information when required by the journal. Selective reporting, undisclosed outcome switching, or misleading presentation of analyses can compromise interpretation.
Exploratory or post hoc analyses may be valuable but should be identified as such rather than presented as prospectively specified outcomes.
Data Sharing Statements
Clinical-trial reports should include data-sharing information when required by the journal, registry, funder, or applicable publishing standard. Statements should describe what data may be shared, with whom, under what conditions, for what period, and through what mechanism where applicable.
A data-sharing statement is a transparency mechanism and does not require public release of data when ethical, privacy, legal, consent, or other legitimate restrictions apply.
Funding, Sponsorship and Investigator Access
Funding and sponsor roles should be disclosed transparently, including material involvement in design, data management, analysis, interpretation, writing, or publication decisions. Where relevant, manuscripts should explain investigator access to data and independence in analysis and publication.
Commercial sponsorship does not automatically determine editorial acceptability, but undisclosed control over data or publication can raise significant transparency concerns.
Secondary Analyses and Multiple Publications
Multiple publications from a trial may be appropriate when they address distinct questions, but related reports should cite each other and should not create a misleading impression of independent evidence or duplicate primary findings.
Secondary analyses should identify the parent trial and registration number and should distinguish prespecified from exploratory analyses where relevant.
Editorial Assessment and Non-Compliance
Editors may request registry records, protocols, amendments, ethics documents, statistical plans, or explanations of discrepancies. Failure to meet registration or reporting requirements should be assessed transparently and consistently according to journal policy and the circumstances of the study.
Suspected fabrication, undisclosed outcome manipulation, or deceptive registration practices may require assessment under the Research Misconduct policy.
Journal Implementation and Version Control
This policy establishes publisher requirements while allowing journals to configure applicable reporting guidelines, registry expectations, protocol-publication practices, and article-type requirements. Those settings should be public and should not be invented or implied where a journal has not adopted them.
Material changes should be versioned and preserved, with particular attention to the requirements in force when participant enrollment and manuscript submission occurred.
Version Control
Version 1.0. This page is the canonical publisher-level text for the current version. Material revisions should be versioned and dated, while superseded versions remain identifiable so that historical applicability can be determined.