What is the CONSORT 2025 checklist?

It is the 30-item checklist of the CONSORT 2025 statement, 42 items with sub-items, listing the minimum a report of a randomised trial should contain. It is organised in six sections: title and abstract, open science, introduction, methods, results and discussion. It was published in April 2025 in the BMJ and other journals, together with an updated flow diagram.

Does CONSORT 2025 replace CONSORT 2010?

Yes. The CONSORT 2025 statement supersedes the CONSORT 2010 statement, which the authors say should no longer be used, and they ask journals to update their instructions to refer to CONSORT 2025. If a journal’s form still lists the 2010 items, fill in the journal’s form, but report the trial to the 2025 standard.

What changed in the CONSORT 2025 checklist?

Seven items were added: data sharing (4), authors’ conflicts of interest (5b), patient and public involvement (8), eligibility of sites and of individuals delivering the interventions (12b), how harms were assessed (15), who is included in each analysis and how missing data were handled (21b, 21c), and how the intervention and comparator were actually delivered, with concomitant care (24a, 24b). Three items were revised, the generalisability item was merged into limitations (30), and a new open science section groups registration, protocol, data sharing and funding.

How do I fill in the CONSORT checklist?

For each item, write where your trial report covers it, for example “Methods, Randomisation, p. 7”. If an item does not apply, such as interim analyses in a trial without any, mark it not applicable and say why. Download the Word file, check the locations against the final manuscript, and upload it as a supplementary file.

Do I need a CONSORT flow diagram as well as the checklist?

Yes. Item 22 asks for the participant flow, and CONSORT strongly recommends a diagram showing the numbers randomly assigned, receiving the intended intervention, lost and analysed in each group. Our free CONSORT flow diagram generator uses the 2025 box wording and checks that the numbers add up.

Is there a CONSORT checklist for cluster, crossover or pilot trials?

Yes. CONSORT extensions cover cluster, crossover, non-inferiority and equivalence, pilot and feasibility, factorial and multi-arm trials, among others. The CONSORT 2025 authors recommend using the existing extensions alongside CONSORT 2025 until they are updated. Start with this checklist and add the extension’s items.

What is the difference between CONSORT and SPIRIT?

SPIRIT covers what to include in a trial protocol, written before the trial starts. CONSORT covers what to include in the report of a completed trial. The 2025 updates of both were developed together, and the wording of some items was aligned so that a protocol written to SPIRIT 2025 maps onto a report written to CONSORT 2025.

Is the CONSORT checklist mandatory?

Many medical journals require a completed CONSORT checklist with every randomised trial, and the ICMJE recommendations encourage authors to follow reporting guidelines such as CONSORT. Check the target journal’s instructions for authors for the version and format it accepts.

Can I reuse the CONSORT 2025 checklist?

Yes. The CONSORT 2025 statement was published open access under the Creative Commons Attribution (CC BY 4.0) licence, so the checklist can be copied and adapted as long as you cite Hopewell et al., BMJ 2025;389:e081123.

Are my answers stored anywhere?

No. The checklist runs in your browser and nothing is sent to a server. Your answers are kept in this browser’s local storage so they are still there when you come back; use “Clear answers” to remove them.

CONSORT 2025 Checklist: Fillable Word Template

Mark each of the 30 CONSORT 2025 items as reported or not applicable and note where it appears in your trial report, from registration and data sharing to harms and limitations. Download the completed checklist as a Word file to upload with your submission. Your answers are saved in this browser only.

Manuscript title (optional)

0 of 42 items done

0 reported · 0 not applicable · 42 open

Show open items only

Title and abstract

1a
Title and structured abstract
Identification as a randomised trial
1b
Title and structured abstract
Structured summary of the trial design, methods, results, and conclusions

Open science

2
Trial registration
Name of trial registry, identifying number (with URL) and date of registration
3
Protocol and statistical analysis plan
Where the trial protocol and statistical analysis plan can be accessed
4
Data sharing
Where and how the individual de-identified participant data (including data dictionary), statistical code and any other materials can be accessed
5a
Funding and conflicts of interest
Sources of funding and other support (eg, supply of drugs), and role of funders in the design, conduct, analysis and reporting of the trial
5b
Funding and conflicts of interest
Financial and other conflicts of interest of the manuscript authors

Introduction

6
Background and rationale
Scientific background and rationale
7
Objectives
Specific objectives related to benefits and harms

Methods

8
Patient and public involvement
Details of patient or public involvement in the design, conduct and reporting of the trial
9
Trial design
Description of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and framework (eg, superiority, equivalence, non-inferiority, exploratory)
10
Changes to trial protocol
Important changes to the trial after it commenced including any outcomes or analyses that were not prespecified, with reason
11
Trial setting
Settings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted
12a
Eligibility criteria
Eligibility criteria for participants
12b
Eligibility criteria
If applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons, physiotherapists)
13
Intervention and comparator
Intervention and comparator with sufficient details to allow replication. If relevant, where additional materials describing the intervention and comparator (eg, intervention manual) can be accessed
14
Outcomes
Prespecified primary and secondary outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome
15
Harms
How harms were defined and assessed (eg, systematically, non-systematically)
16a
Sample size
How sample size was determined, including all assumptions supporting the sample size calculation
16b
Sample size
Explanation of any interim analyses and stopping guidelines
17a
Sequence generation
Who generated the random allocation sequence and the method used
17b
Sequence generation
Type of randomisation and details of any restriction (eg, stratification, blocking and block size)
18
Allocation concealment mechanism
Mechanism used to implement the random allocation sequence (eg, central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions were assigned
19
Implementation
Whether the personnel who enrolled and those who assigned participants to the interventions had access to the random allocation sequence
20a
Blinding
Who was blinded after assignment to interventions (eg, participants, care providers, outcome assessors, data analysts)
20b
Blinding
If blinded, how blinding was achieved and description of the similarity of interventions
21a
Statistical methods
Statistical methods used to compare groups for primary and secondary outcomes, including harms
21b
Statistical methods
Definition of who is included in each analysis (eg, all randomised participants), and in which group
21c
Statistical methods
How missing data were handled in the analysis
21d
Statistical methods
Methods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing prespecified from post hoc

Results

22a
Participant flow, including flow diagram
For each group, the numbers of participants who were randomly assigned, received intended intervention, and were analysed for the primary outcome
22b
Participant flow, including flow diagram
For each group, losses and exclusions after randomisation, together with reasons
23a
Recruitment
Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms
23b
Recruitment
If relevant, why the trial ended or was stopped
24a
Intervention and comparator delivery
Intervention and comparator as they were actually administered (eg, where appropriate, who delivered the intervention/comparator, how participants adhered, whether they were delivered as intended (fidelity))
24b
Intervention and comparator delivery
Concomitant care received during the trial for each group
25
Baseline data
A table showing baseline demographic and clinical characteristics for each group
26
Numbers analysed, outcomes and estimation
For each primary and secondary outcome, by group: • the number of participants included in the analysis • the number of participants with available data at the outcome time point • result for each group, and the estimated effect size and its precision (such as 95% confidence interval) • for binary outcomes, presentation of both absolute and relative effect size
27
Harms
All harms or unintended events in each group
28
Ancillary analyses
Any other analyses performed, including subgroup and sensitivity analyses, distinguishing pre-specified from post hoc

Discussion

29
Interpretation
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
30
Limitations
Trial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analyses

Items 17a to 19 (sequence generation, allocation concealment mechanism and implementation) form the randomisation section of the methods.

The CONSORT 2025 explanation and elaboration article discusses each item with published examples. Extensions cover cluster, crossover, non-inferiority, pilot, factorial and other trial designs.

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What the CONSORT 2025 checklist covers

CONSORT, Consolidated Standards of Reporting Trials, sets out the minimum a report of a randomised trial should contain. The 2025 update has 30 items, 42 with sub-items, and replaces CONSORT 2010. It adds a section on open science and new items on data sharing, conflicts of interest, patient and public involvement, harms, missing data and how the interventions were actually delivered.

The checklist focuses on two-group parallel trials, with extensions for other designs. For what changed and how editors use it, see our guide to CONSORT 2025. For item 22, draw the participant flow with our CONSORT flow diagram generator.

The six sections at a glance

Sections of the CONSORT 2025 checklist and their items
Section	Items	What to report
Title and abstract	1	Identify the study as a randomised trial and give a structured summary.
Open science	2–5	Registration, protocol and statistical analysis plan, data sharing, funding and conflicts of interest.
Introduction	6–7	Background, rationale and objectives for benefits and harms.
Methods	8–21	Patient and public involvement, design, changes, setting, eligibility, interventions, outcomes, harms, sample size, randomisation, blinding and statistical methods.
Results	22–28	Participant flow, recruitment, intervention delivery, baseline data, outcomes and estimation, harms and ancillary analyses.
Discussion	29–30	Interpretation balancing benefits and harms, and limitations including generalisability.

How to complete and submit it

Fill it in against the final manuscript, including the protocol and statistical analysis plan you cite for item 3.
Give a location for every item and sub-item. Section names survive reformatting better than page numbers.
Mark not applicable items with a reason, for example “No interim analyses planned” for 16b.
Add the flow diagram for item 22. The flow diagram generator checks that randomised, allocated, lost and analysed numbers add up.
Write the open science statements: our data availability statement generator covers item 4 and the conflict of interest statement generator covers item 5b.

Frequently asked questions

What is the CONSORT 2025 checklist?: It is the 30-item checklist of the CONSORT 2025 statement, 42 items with sub-items, listing the minimum a report of a randomised trial should contain. It is organised in six sections: title and abstract, open science, introduction, methods, results and discussion. It was published in April 2025 in the BMJ and other journals, together with an updated flow diagram.
Does CONSORT 2025 replace CONSORT 2010?: Yes. The CONSORT 2025 statement supersedes the CONSORT 2010 statement, which the authors say should no longer be used, and they ask journals to update their instructions to refer to CONSORT 2025. If a journal’s form still lists the 2010 items, fill in the journal’s form, but report the trial to the 2025 standard.
What changed in the CONSORT 2025 checklist?: Seven items were added: data sharing (4), authors’ conflicts of interest (5b), patient and public involvement (8), eligibility of sites and of individuals delivering the interventions (12b), how harms were assessed (15), who is included in each analysis and how missing data were handled (21b, 21c), and how the intervention and comparator were actually delivered, with concomitant care (24a, 24b). Three items were revised, the generalisability item was merged into limitations (30), and a new open science section groups registration, protocol, data sharing and funding.
How do I fill in the CONSORT checklist?: For each item, write where your trial report covers it, for example “Methods, Randomisation, p. 7”. If an item does not apply, such as interim analyses in a trial without any, mark it not applicable and say why. Download the Word file, check the locations against the final manuscript, and upload it as a supplementary file.
Do I need a CONSORT flow diagram as well as the checklist?: Yes. Item 22 asks for the participant flow, and CONSORT strongly recommends a diagram showing the numbers randomly assigned, receiving the intended intervention, lost and analysed in each group. Our free CONSORT flow diagram generator uses the 2025 box wording and checks that the numbers add up.
Is there a CONSORT checklist for cluster, crossover or pilot trials?: Yes. CONSORT extensions cover cluster, crossover, non-inferiority and equivalence, pilot and feasibility, factorial and multi-arm trials, among others. The CONSORT 2025 authors recommend using the existing extensions alongside CONSORT 2025 until they are updated. Start with this checklist and add the extension’s items.
What is the difference between CONSORT and SPIRIT?: SPIRIT covers what to include in a trial protocol, written before the trial starts. CONSORT covers what to include in the report of a completed trial. The 2025 updates of both were developed together, and the wording of some items was aligned so that a protocol written to SPIRIT 2025 maps onto a report written to CONSORT 2025.
Is the CONSORT checklist mandatory?: Many medical journals require a completed CONSORT checklist with every randomised trial, and the ICMJE recommendations encourage authors to follow reporting guidelines such as CONSORT. Check the target journal’s instructions for authors for the version and format it accepts.
Can I reuse the CONSORT 2025 checklist?: Yes. The CONSORT 2025 statement was published open access under the Creative Commons Attribution (CC BY 4.0) licence, so the checklist can be copied and adapted as long as you cite Hopewell et al., BMJ 2025;389:e081123.
Are my answers stored anywhere?: No. The checklist runs in your browser and nothing is sent to a server. Your answers are kept in this browser’s local storage so they are still there when you come back; use “Clear answers” to remove them.

Sources

Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ 2025;389:e081123. doi:10.1136/bmj-2024-081123. Distributed under CC BY 4.0.
Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ 2025;389:e081124.
CONSORT and SPIRIT Group. CONSORT and SPIRIT website.
EQUATOR Network. CONSORT reporting guideline.

Content updated November 15, 2026. This is an independent tool and is not affiliated with the CONSORT Group. Check your target journal’s instructions for the form it requires.