CONSORT Checklist RCT Template — Free Download

The 25 CONSORT 2010 Checklist Items

Schulz et al., BMJ 2010;340:c332 · JAMA 2010;303(6):598–605.

#	Section / Topic	What to report
1a	Title	Identification as randomised trial in the title.
1b	Abstract	Structured summary of trial design, methods, results, and conclusions (CONSORT abstract format).
2a	Background	Scientific background and explanation of rationale for the trial.
2b	Objectives	Specific objectives or hypotheses.
3a	Trial design	Description of trial design (parallel, factorial, etc.), including allocation ratio.
3b	Changes to design	Important changes to trial design after commencement, with reasons.
4a	Participants	Eligibility criteria for participants and settings and locations of data collection.
5	Interventions	Sufficient detail to allow replication: what was given, to whom, how, and when.
6a	Outcomes	Pre-specified primary and secondary outcome measures with timepoints.
7a	Sample size	How sample size was determined.
8a	Randomisation — sequence	Method used to generate the random allocation sequence.
8b	Randomisation — type	Type (simple, block, stratified) and any restriction details.
9	Allocation concealment	Mechanism used to implement the random allocation sequence (central allocation, sequentially numbered containers, etc.).
10	Implementation	Who generated the allocation sequence, enrolled participants, and assigned participants to interventions.
11a	Blinding	If done, who was blinded after assignment to interventions.
12a	Statistical methods	Methods for primary and secondary outcomes, including multiplicity adjustments.
13a	Participant flow	Numbers randomised, receiving treatment, completing follow-up, analysed for primary outcome.
14a	Recruitment	Dates defining the periods of recruitment and follow-up.
15	Baseline data	Demographic and clinical characteristics of each group.
16	Numbers analysed	Number of participants in each group included in each analysis, whether intention-to-treat.
17a	Outcomes and estimation	Results for each primary and secondary outcome, including estimated effect size and precision (95% CI).
18	Ancillary analyses	Subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory.
19	Harms	All important harms or unintended effects in each group.
20	Limitations	Trial limitations, sources of potential bias, and imprecision.
21	Generalisability	Generalisability (external validity, applicability) of the trial findings.
22	Interpretation	Interpretation consistent with results, balancing benefits and harms, considering other evidence.
23	Registration	Registration number and registry name.
24	Protocol	Where the full trial protocol can be accessed.
25	Funding	Sources of funding and other support; role of funders.

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CONSORT reporting tips

Does CONSORT require a CONSORT flow diagram?

Yes — item 13 requires a participant flow diagram showing numbers at each stage: assessed for eligibility, excluded (with reasons), randomised, received allocated intervention, lost to follow-up, and analysed. CliniDraft generates a text description that you can use to create the diagram in a drawing tool.

What is the difference between per-protocol and intention-to-treat analysis?

Intention-to-treat (ITT) analysis includes all randomised participants in their assigned group regardless of adherence — this preserves randomisation and is the primary analysis in most RCTs. Per-protocol analysis includes only those who adhered to the protocol. Both should be reported; the difference indicates the impact of non-adherence.

Does my trial need to be registered before submission?