In short: Many medical journals follow the ICMJE recommendation that a clinical trial must be registered in a public registry at or before the time of first patient consent for enrolment. Report the trial with the current CONSORT 2025 checklist and flow diagram, put the registration number at the end of the abstract, and include a data sharing statement. Expect the journal to ask about the protocol, ethics approval and consent. Late registration cannot be fixed at submission, so check it before you start writing.
By On Time Publication Editorial Team · Last updated 15 October 2026
The ICMJE defines a clinical trial as any research project that prospectively assigns people, or a group of people, to an intervention, with or without a comparison or control group, to study the relationship between a health-related intervention and a health outcome. Its examples include drugs, surgical procedures, devices, behavioural treatments, educational programmes, dietary interventions, quality improvement interventions and process-of-care changes (ICMJE). So a hospital education or quality improvement study can count. The ICMJE encourages, but does not require, registration of observational studies.
When we checked the WHO list of primary registries on 15 October 2026, it did not include a registry based in a GCC country or Jordan. Researchers there can use ClinicalTrials.gov or another primary registry. Your ethics committee, institution or national regulator may have its own requirements as well, so ask them.
Since 1 July 2018, manuscripts reporting clinical trial results that are submitted to ICMJE journals must contain a data sharing statement, and trials that began enrolling on or after 1 January 2019 must include a data sharing plan in their registration. The statement must say whether de-identified individual participant data will be shared ("undecided" is not acceptable), what data, which related documents (such as the protocol), when and for how long, and on what access criteria. If the plan changes, update the registry record too.
CONSORT 2025 was published on 14 April 2025, in five leading medical journals at once. It has a 30-item checklist and a participant flow diagram, adds a new open science section (registration, access to the protocol and statistical analysis plan, data sharing, funding and conflicts of interest), and adds new items such as patient and public involvement. Its authors state that CONSORT 2025 supersedes CONSORT 2010, which should no longer be used (CONSORT 2025). Use it with the explanation and elaboration paper.
Requirements vary, so read the guide for authors. As one example, PLOS One asks for the registry name and number in the abstract, the ethics-approved protocol and a completed CONSORT checklist as supporting information, and the CONSORT flow diagram as Figure 1, and says any deviation from the protocol must be explained (PLOS One). Typical items:
The ICMJE does not treat results posted in a registry as prior publication if they are limited to a brief structured abstract or tables, but authors must explain any difference between the registry and the paper.
Registering the trial and reporting it accurately are the investigators' responsibility. Our medical manuscript editing covers language, clarity and journal formatting for clinical papers. A reporting-guideline checklist review (CONSORT, PRISMA, STROBE, CARE and similar) is included in every medical edit, and we check that ethics approval, informed consent, trial registration and conflict-of-interest statements are present and clearly worded, flagging missing items for you to add. Our team of qualified researchers and subject-specialist editors with publishing experience can also help you shortlist journals through journal submission support. An NDA is available on request, with Arabic support and Gulf and Jordan business hours. We give a custom quote based on word count, field and deadline after a free assessment, and we agree turnaround per quote. You can pay by Stripe, PayPal or bank transfer in USD, GBP, SAR, AED, JOD and other currencies; itemised invoices are available on request. Acceptance is always decided by the journal's editors and peer reviewers.
Independence: On Time Publication is not affiliated with Elsevier/Scopus, Clarivate/Web of Science, COPE, the ICMJE, the US National Library of Medicine (NLM), ClinicalTrials.gov, the WHO, the SPIRIT-CONSORT Group, EQUATOR, PLOS or any journal or publisher named on this page. We have no office in the GCC or Jordan. We link to public guidance so you can check it yourself.
In many medical journals, yes. The ICMJE recommends that editors require registration in a public trials registry as a condition of considering the paper.
At or before the time of first patient consent for enrolment, according to the ICMJE. Registration at the time of submission is too late for that purpose.
The ICMJE accepts ClinicalTrials.gov and any primary registry of the WHO ICTRP that includes the minimum 24-item data set. Check the WHO's current list of primary registries.
Possibly, but it is harder. The ICMJE says exceptions should be rare and that trials not registered prospectively risk being inadmissible to ICMJE journals. If an exception is made, the paper should say when registration was completed and why it was delayed.
Not under the ICMJE policy, if the posted results are limited to a brief structured abstract or tables. You must explain any differences between the registry results and your paper.
CONSORT 2025, published in April 2025. Its authors say it supersedes CONSORT 2010, which should no longer be used. Check the EQUATOR Network for extensions for special designs.
A statement saying whether de-identified participant data will be shared, what data and documents, when, for how long and on what access criteria. ICMJE journals require one for clinical trial reports.
The ICMJE encourages registration of observational studies but does not require it. Your journal or ethics committee may have its own policy.
We link to official sources so you can check the rules yourself. Always follow your target journal's and institution's current instructions.
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