checklist / Reporting guideline checklist

CONSORT Checklist for Clinical Trial Manuscripts

A practical CONSORT 2025 checklist guide for randomized clinical trial manuscripts, including open science, methods, results, harms, and flow diagram requirements.

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What CONSORT checklist should authors use for clinical trial manuscripts?

Authors reporting randomized clinical trial results should use CONSORT 2025, which includes a 30-item checklist and participant flow diagram. The manuscript should report trial registration, protocol and statistical analysis plan access, data sharing, funding and conflicts, study design, participants, interventions, outcomes, randomization, blinding, statistical methods, results, harms, limitations, and interpretation.

Short answer

Use CONSORT 2025 when reporting randomized trial results. A clinical trial manuscript should include a completed CONSORT checklist, a participant flow diagram, trial registration details, protocol and statistical analysis plan access, data-sharing information, funding and conflict disclosures, and transparent reporting of design, methods, results, harms, and limitations.

What changed for CONSORT 2025

  • CONSORT 2025 is the current reporting guideline for randomized trial results.
  • The checklist has 30 items plus a participant flow diagram.
  • The checklist adds an open science section covering trial registration, protocol and statistical analysis plan access, data sharing, funding, and conflicts of interest.
  • The 2025 update places more emphasis on patient and public involvement, harms assessment, missing data, and how the intervention and comparator were actually administered.
  • Authors should also check trial-specific CONSORT extensions when the design is cluster randomized, crossover, multi-arm, non-inferiority, pragmatic, or focused on harms or outcomes.

Pre-submission checklist

  • Title identifies the study as a randomized trial.
  • Abstract reports trial design, participants, interventions, outcomes, key results, harms, conclusions, registration, and funding.
  • Methods describe eligibility, setting, intervention, comparator, outcomes, sample size, randomization, allocation concealment, blinding, statistical methods, harms collection, and missing data handling.
  • Results report participant flow, recruitment dates, baseline data, numbers analyzed, primary and secondary outcomes, effect estimates, precision, ancillary analyses, harms, and intervention adherence or delivery.
  • Discussion explains interpretation, limitations, generalizability, and how conclusions match the evidence.
  • Open science items identify trial registry, protocol, statistical analysis plan, data-sharing availability, funding, and conflicts of interest.
  • A CONSORT flow diagram follows participants from assessment through randomization, allocation, follow-up, and analysis.

How SciPaperX helps

SciPaperX can review a randomized trial manuscript for missing CONSORT 2025 elements, inconsistent denominators, weak abstract reporting, incomplete registration details, missing harms language, and submission-package gaps before journal upload.