Clinical Trial Manuscript Submission Checklist: Registration, Protocol, SAP, CONSORT 2025 Checklist and Data Sharing Statement

ICMJE journals require registration in a public registry at or before the time of first patient consent, as a condition of publication [3, 4]. Acceptable registries are ClinicalTrials.gov or a WHO ICTRP primary registry, and the registration number should appear at the end of the abstract [3]. The registered primary outcome must match the manuscript. If registration was late, state the date and the reason; ICMJE expects such exceptions to be rare and explained [3].

• Registry name, number and date of registration versus date of first enrolment.
• Registered primary outcome, time point and measurement method identical to the manuscript.
• Dated history of registry amendments explained in the methods.

SPIRIT 2025 updates the protocol standard alongside CONSORT 2025, so the protocol and results report share structure and terminology [5]. Submit the protocol version that governed the trial, with version numbers and dates for all amendments. Selective outcome reporting is found by comparing protocols with publications: in one landmark comparison, 62% of trials had at least one primary outcome changed, introduced or omitted [2].

Finalise the statistical analysis plan (SAP) before the blind is broken [6]. Gamble and colleagues define minimum SAP content, including analysis populations, the primary analysis model, covariate adjustment, handling of missing data, multiplicity, interim analyses and sensitivity analyses [7]. Our SAP guide covers each element.

Define the estimand for the primary outcome. ICH E9(R1) gives it five attributes: the population, the treatment conditions compared, the variable (endpoint), the handling of intercurrent events such as treatment discontinuation or rescue medication, and the population-level summary measure [8]. State the strategy for each intercurrent event (treatment policy, hypothetical, composite, while on treatment or principal stratum) and align the primary and sensitivity analyses with it, so that missing-data assumptions are explicit.

• SAP version and date preceding unblinding.
• Any deviation from the SAP reported in the manuscript, with its rationale.

CONSORT 2025 is a 30-item checklist with a participant flow diagram. The update added seven items, revised three and deleted one, integrated items from the Harms, Outcomes and Non-pharmacological Treatment extensions and TIDieR, and introduced a new open science section [1]. Complete the checklist with page numbers, not “yes/no” entries.

• Open science section: registration, protocol and SAP access, data sharing, funding and conflicts of interest.
• Flow diagram with numbers assessed, randomised, allocated, lost to follow-up and analysed per arm.
• Harms reported systematically for each group, not only serious adverse events.
• Intervention described in enough detail for replication.

Since 1 July 2018, ICMJE journals require a data sharing statement in reports of clinical trials, and trials that begin enrolling on or after 1 January 2019 must include a data sharing plan in the registration record [9]. The statement should say whether individual participant data will be shared, which data, which supporting documents (protocol, SAP, analytic code), when, with whom, for what analyses and by what mechanism. A statement that data will not be shared is acceptable if it is explicit; it should match the registry entry.

The abstract is screened first and must stand alone. CONSORT 2025 keeps a structured abstract checklist: the title identifies the study as a randomised trial, and the abstract reports the design, participants, interventions, primary outcome, results for each group with effect size and precision, harms, conclusions, registration and funding [1]. The primary outcome in the abstract must use the same name, time point and analysis population as the registry entry.

Report each primary and secondary outcome with the result for each group, the estimated effect size and its 95% confidence interval; for binary outcomes give absolute and relative effects. Separate pre-specified secondary and exploratory analyses from post hoc ones, and flag any outcome added after registration. This is where outcome switching and selective reporting are most often detected [2].

Before journal submission, build a one-page table comparing the registry, protocol, SAP and manuscript on six fields: primary outcome definition, time point, target sample size, randomisation method, analysis population and primary statistical model. Explain any difference in the methods with the date and reason. Including the table in the cover letter can shorten editorial screening and anticipates a statistical reviewer’s questions. Our guide to mapping outputs to the SAP shows how to keep results traceable.

• Primary outcome and time point identical across all four documents.
• Sample size parameters (effect size, power, alpha, attrition) reproduced exactly.
• Analysis population (intention-to-treat, modified, per-protocol) defined once and used consistently.
• Interim analyses and stopping rules reported if the protocol or SAP specified them [7].

Copy Table 1 into your submission folder and tick each item before journal submission. These checks support research transparency, reproducibility and publication readiness during peer review.