Clinical Trial Registration Policy
Clinical Trial Registration Policy
Clinical trials must be registered in a public registry before the first participant is enrolled. Registration after the fact does not qualify, because the point of registering is to fix the outcomes before the results are known.
Last reviewed August 2026 · Applies to all submissions to JMVRA (ISSN 2984-8911)
Prospective registration exists to solve two specific problems. Publication bias: trials with disappointing results quietly never get written up, so the published literature overstates how well treatments work. Outcome switching: a trial that misses its primary endpoint gets reported around a secondary one that happened to reach significance. A public registration entered before enrolment makes both visible.
Which Studies Must Register
Registration Required
- Any study prospectively assigning people to an intervention to evaluate its effect on a health outcome
- Drug, device, surgical and procedural trials
- Behavioural, dietary and physiotherapy interventions
- Randomised and non-randomised controlled trials
- Pilot and feasibility trials with health outcomes
- Trials of traditional, herbal and alternative medicine
Registration Not Required
- Purely observational studies with no assigned intervention
- Retrospective chart and database reviews
- Case reports and case series
- Laboratory and animal studies
- Surveys with no health intervention
- Systematic reviews (registration in PROSPERO is encouraged)
Accepted Registries
Any registry meeting the WHO International Clinical Trials Registry Platform criteria is accepted — it must be publicly accessible, free to search, electronically searchable, open to all prospective registrants, and managed by a not-for-profit body.
CTRI (India)
Clinical Trials Registry – India. Mandatory for trials conducted in India under DCGI rules.
ClinicalTrials.gov
The United States registry, and the most widely used internationally.
ISRCTN
International registry accepting trials from any country.
EU CTR / EudraCT
The European Union clinical trials register.
ANZCTR, ChiCTR, UMIN
Australia/New Zealand, China and Japan national registries.
WHO ICTRP
The search portal aggregating all WHO-compliant primary registries.
What the Manuscript Must Contain
- Registry name and registration number at the end of the abstract, so it is visible to anyone reading only the abstract.
- Date of registration and date of first enrolment, both stated, so a reader can verify registration came first.
- A direct URL to the public registry record.
- CONSORT-compliant reporting, including a participant flow diagram. The checklist may be requested during review.
- The trial protocol supplied as a supplementary file wherever possible.
- Any change to the registered primary outcome declared explicitly, with the reason and the date it was made.
- Ethics approval as required by the Human & Animal Ethics Policy.
- Funding and sponsor declared, together with any role the funder had in design, analysis or the decision to publish.
Outcome Switching
Where the outcomes reported in a manuscript differ from those registered, reviewers will ask. Changing a primary outcome is not automatically improper — there are legitimate reasons, such as a protocol amendment made before unblinding. What is required is that the change is declared and dated, so a reader can see it was not made after the results were known. An undeclared change discovered after publication is grounds for a correction or, where it materially misrepresents the trial, a retraction.
Where the Clinical Trial Registration Policy Applies
The stages of a paper’s journey this policy governs are highlighted.
Applies at: Prepare · Submit · Review
Clinical Trial Registration Policy in Brief
A clinical trial must be registered in a recognised public registry before the first participant is enrolled. Registration made after enrolment does not qualify, because the purpose of registering is to fix the planned outcomes before anyone knows the results.
The registration number and registry must appear in the manuscript, and the reported outcomes must match the registered ones — or any change must be explained openly. This follows the ICMJE standard and protects readers from selective reporting.
