Purpose and Scope
This policy applies to submissions reporting clinical trials — prospective studies assigning human participants to interventions to evaluate health-related effects, as understood in recognised international definitions — and to secondary analyses and protocol papers arising from them.
Prospective Registration
Applicable trials shall be registered in a public registry that is a primary registry of the WHO ICTRP network, ClinicalTrials.gov, or another registry meeting recognised standards of accessibility, free public access and the required minimum dataset. Registration shall occur at or before first participant consent for enrolment. Prospective registration is the required default and ordinarily a condition of consideration for publication, not merely a reporting preference. A rare exception may be considered only under the safeguards in the Late and Retrospective Registration section below.
The manuscript shall state the registry name, the trial registration number and the date of registration, in a location readily identifiable to readers, editors and reviewers.
Consistency Between Registry and Manuscript
The registry entry and the manuscript shall be consistent as to the trial's design, participants, interventions, and primary and secondary outcomes. Editors and reviewers may compare the two, and authors shall explain any discrepancy. Undisclosed changes to primary outcomes between registration and publication — outcome switching — materially affect the reliability of reported findings and shall be disclosed and explained; concealment may be assessed under C5.
Protocol Transparency and Deviations
Authors shall make the trial protocol and statistical analysis plan available to editors and reviewers on request, and are encouraged to publish or deposit them, with version and date. Material deviations from the registered protocol or analysis plan — in eligibility, intervention, outcome definition, sample size or analysis strategy — shall be reported in the manuscript with the reason and the date the change was made, distinguishing pre-specified from post hoc analyses.
Late and Retrospective Registration
Registration after enrolment has begun is not equivalent to prospective registration and shall not be presented as though it were. Before any exceptional consideration of a late-registered trial, the trial must be registered publicly and the editor shall document whether the failure to register prospectively was intended to cause, or was likely to have caused, selective or biased reporting. Exceptions shall be rare and require a compelling justification, an assessment that the integrity of the report can still be evaluated, prominent disclosure in the article of when registration occurred and why it was delayed, and a published editorial statement explaining why the exception was allowed. Each journal shall state its implementation consistently with this minimum. LMI does not operate its own trial registry and does not accept registration in a non-public or proprietary record as satisfying this policy.
Related Requirements
Trials remain subject to D1 (ethics approval and consent), D4 (reporting standards, including recognised trial-reporting and protocol guidance such as CONSORT and SPIRIT), and E2 (data availability). Falsified registration records are addressed under C3 and C5.
Standards and Guidance
Informed by the ICMJE Recommendations on trial registration and data sharing, and WHO trial-registration standards.