CONSORT Flow Diagram: Participant Counts from Enrollment to Analysis
Explore a CONSORT flow diagram generator to draft participant flow for a two-arm randomized trial. Check enrollment, allocation and analysis counts before reporting.
Use a CONSORT flow diagram generator to draft participant flow through enrollment, randomization, allocation, follow-up and analysis. Start from your verified trial records, keep each trial arm distinct and explain missing data instead of assuming everyone lost to follow-up was excluded from analysis.
Use the CONSORT Flow Diagram Generator to start a draft, then check it against the reference points below.
Original AI-generated consort flow diagram reference commissioned by AcaDraw. Fictional two-arm trial counts; not research findings or evidence of compliance.
The diagram follows people, not literature records
A CONSORT flow diagram summarizes a randomized trial’s participant path. Enrollment counts describe who was assessed and excluded; allocation identifies the trial arms; follow-up and analysis report what happened afterward. PRISMA, by contrast, follows literature records and reports through a systematic review.
Do not reuse PRISMA labels for a trial simply because both figures contain boxes and arrows. The unit being counted and the decisions represented are different.
A fictional example that reconciles
Suppose 120 people were assessed, 20 were excluded before randomization and 100 were randomized. A two-arm allocation of 50 and 50 reconciles with that total. Each exclusion reason should have a count and a definition traceable to the trial records.
Now suppose three people in arm A and two in arm B lack follow-up information. Those losses are not automatically analysis exclusions. An analysis may retain all randomized participants with a specified missing-data strategy; another analysis population may differ and needs explanation. The example must say which approach is being illustrated.
Arithmetic checks are necessary but limited
The local CONSORT count check checks enrollment subtraction and allocation totals. It also flags impossible or incomplete counts. It does not validate the trial design, an imputation method, the eligibility decisions or compliance with a reporting guideline.
Before publication, compare every number with source records and use current CONSORT guidance and the relevant extension for the trial design. Keep the participant-flow diagram separate from outcome evidence. Never fill an empty result or analysis section with generated plausible-looking research findings.
CONSORT Flow Diagram reference key
| Element | Meaning | Review check |
|---|---|---|
| Enrollment | Assessed and excluded before randomization | Explain exclusions and reconcile assessed minus excluded with randomized. |
| Randomization | Participants assigned to trial arms | Check that allocated totals equal the randomized population. |
| Allocation | Participants allocated to each intervention | Report receipt of intervention and reasons for nonreceipt where relevant. |
| Follow-up | Losses and discontinuations by arm | Follow-up loss does not automatically mean exclusion from analysis. |
| Analysis | Participants included in each defined analysis | State the population, exclusions and missing-data methods. |
A brief for the visual draft
Create an editable flow diagram for a fictional two-arm parallel trial: assessed 120, excluded 20, randomized 100, allocated 50 to A and 50 to B. Show follow-up losses of 3 and 2 separately. Analyze all 50 in each arm with a placeholder for the stated missing-data method. Label the example fictional and do not invent trial outcomes.
Checks before sharing
Arms that do not add up. Allocated counts should reconcile with randomized participants under the stated design.
Lost equals excluded. Participants lost to follow-up may still belong in a defined analysis population.
Template treated as compliance. A flow diagram alone does not establish reporting completeness, trial quality or guideline compliance.
Common questions
What does a CONSORT flow diagram show?
It summarizes participant progress through enrollment, allocation, follow-up and analysis in a randomized trial.
Is it the same as a PRISMA flow diagram?
No. CONSORT follows trial participants; PRISMA describes identification and selection of reports for a systematic review.
Should follow-up losses be subtracted from analysis?
Not automatically. The analysis population and missing-data method determine how participants are handled. Explain them explicitly.
Does the count checker validate my trial?
No. It checks a few arithmetic relationships only, not protocol adherence, missing-data validity or CONSORT compliance.
Sources and editorial notes
Prepared by the AcaDraw product team on November 10, 2026. The illustration is an original AI-generated teaching example. Reference links support the concepts; they do not imply endorsement or independent review of this article.
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