Clinical Trial Paper Checker (CONSORT)

Clinical trial reporting is among the most regulated areas of academic publishing. Journals enforce CONSORT guidelines, regulatory bodies mandate trial registration, and ethics committees require specific documentation — all before your paper reaches peer review. The consequences of incomplete reporting aren't just desk rejection: missing elements can raise concerns about research integrity and trigger editorial investigations. Getting the formatting right from the start protects both your publication timeline and your professional reputation.

CONSORT 2010: The Non-Negotiable Checklist

The CONSORT (Consolidated Standards of Reporting Trials) 2010 statement provides a 25-item checklist that virtually every medical journal requires for randomized controlled trials. Leading journals — The Lancet, BMJ, JAMA, NEJM — will desk-reject any RCT paper that doesn't demonstrate CONSORT compliance.

Key checklist items that are most commonly missing or incomplete:

1. Trial registration number and registry name in the abstract (CONSORT Item 1b). Must include ClinicalTrials.gov, ISRCTN, or equivalent registration number.
2. CONSORT flow diagram showing participant enrollment, allocation, follow-up, and analysis. This figure is mandatory, not optional.
3. Sample size calculation (Item 7a): how was the sample size determined? What power calculation was used? What was the expected effect size?
4. Randomization details (Items 8–10): sequence generation method, allocation concealment mechanism, and who was blinded.
5. Primary and secondary outcomes (Item 6a): clearly defined with measurement methods and time points.
6. Harms reporting (Item 19): adverse events must be reported even if none occurred. "No adverse events were observed" is required.

CheckMyManuscript scans for the structural elements of CONSORT compliance: trial registration numbers, flow diagrams, sample size sections, randomization descriptions, and adverse event reporting. We flag papers where any of these required sections are missing.

Trial Registration Requirements

Prospective trial registration — registering before enrollment of the first participant — is an ethical and editorial requirement. The International Committee of Medical Journal Editors (ICMJE) mandates registration in an approved public registry for all trials:

• ClinicalTrials.gov (U.S.)
• ISRCTN (international)
• EU Clinical Trials Register
• WHO-approved national registries (ANZCTR, CTRI, ChiCTR, etc.)

Your manuscript must include the registry name and registration number in the abstract and methods. Retrospective registration (after enrollment began) must be disclosed — some journals will still publish retrospectively registered trials with a disclosure, while others reject them outright.

Extensions for Specific Trial Types

Standard CONSORT covers parallel-group RCTs. If your trial has a different design, you need the appropriate CONSORT extension:

• Cluster randomized trials — CONSORT extension with additional items for unit of randomization, intracluster correlation, and cluster-level analyses
• Non-inferiority/equivalence trials — requires pre-specified margin, justification, and appropriate statistical framework
• Crossover trials — period effects, carryover, and washout documentation
• Pilot/feasibility studies — CONSORT extension with feasibility-specific outcomes
• Adaptive trials — pre-planned decision rules and interim analysis documentation

Using the wrong CONSORT extension — or using standard CONSORT for a non-standard design — is a common error that editors catch immediately.

Statistical Reporting Standards

Clinical trial papers have specific statistical reporting requirements:

• Intention-to-treat analysis is the default. If you used per-protocol analysis, justify it and present ITT results as well.
• Confidence intervals must accompany all primary outcomes (95% CI standard). P-values alone are insufficient.
• Multiple comparisons: if your trial has multiple primary outcomes or interim analyses, explain your adjustment method (Bonferroni, Holm, etc.).
• Missing data: describe how missing data were handled (last observation carried forward, multiple imputation, complete case analysis) and justify the approach.

Also see: [Medical paper checker](/for/medical-papers) | [PLOS journal checker](/for/plos-journals) | [How to avoid desk rejection](/desk-rejection)