Clinical Trial Registration Policy

1. Policy Statement

Physical Education and Sports: Studies and Research (PESSR) is committed to transparency, research integrity, and the responsible reporting of intervention studies involving human participants.

PESSR adopts the principles of clinical trial registration recommended by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO).

Prospective registration of eligible clinical trials is required as a condition of consideration for publication, subject only to the exceptional circumstances described below.

2. Definition and Scope

In accordance with the ICMJE definition, a clinical trial is a research project that prospectively assigns individuals or groups of individuals to one or more health-related interventions to evaluate their effects on health-related outcomes.

Clinical trials may include randomized, non-randomized, controlled, or uncontrolled intervention studies.

Within the scope of PESSR, potentially eligible interventions include, but are not limited to:

Physical education and school-based exercise programs evaluating health-related outcomes.
Exercise interventions designed to improve physical fitness, physiological health, or health-related functioning.
Injury prevention and rehabilitation interventions.
Behavioral or educational interventions evaluating health-related outcomes.
Other prospectively assigned interventions intended to modify biomedical or health-related outcomes.

Classification depends on the study design, intervention, and outcomes rather than the terminology selected by the authors.

Observational studies and interventions that do not investigate health-related outcomes are not automatically classified as clinical trials. The Editorial Office may request clarification when trial eligibility is uncertain.

3. Prospective Trial Registration

All clinical trials falling within this policy must be registered in a publicly accessible and ICMJE-acceptable trial registry at or before the time of first participant consent for enrollment.

Acceptable registries include:

ClinicalTrials.gov.
ISRCTN.
WHO International Clinical Trials Registry Platform (ICTRP) Primary Registries.
Other registries meeting the current ICMJE registration requirements.

The registry record must contain sufficient information about the study design, intervention, recruitment, prespecified outcomes, and other required trial registration data.

Registration of a study protocol on the Open Science Framework (OSF) or a similar general-purpose repository may support research transparency but does not, by itself, satisfy the clinical trial registration requirement unless the registration service independently meets ICMJE criteria.

Ethical approval and trial registration are separate requirements. Approval from a Research Ethics Committee or Institutional Review Board does not replace prospective trial registration.

4. Information Required at Submission

Authors submitting manuscripts reporting clinical trials must provide:

The name of the trial registry.
The trial registration number or unique identifier.
The registration date.
A direct URL to the publicly accessible registration record.
The date of first participant enrollment.
A statement identifying the ethics committee, approval number, and approval date.
A description of any material deviations from the registered protocol or prespecified outcomes.
A data sharing statement, consistent with applicable ICMJE recommendations.

The trial registration number must be reported at the end of the manuscript abstract and in the Methods section.

Authors must ensure consistency among the registry record, study protocol, submitted manuscript, and reported results. Any substantial discrepancies must be explained.

5. Retrospective Registration and Unregistered Trials

Retrospective trial registration does not satisfy the requirement for prospective registration.

Manuscripts reporting unregistered clinical trials will not ordinarily be considered for publication.

In rare and justified circumstances, the Editorial Office may evaluate a manuscript involving delayed registration. Such consideration is not guaranteed and requires the trial to be registered in an acceptable registry, a documented explanation of the delay, and an editorial assessment of potential selective reporting or bias.

If an exception is granted, the published article must clearly disclose the registration date, reasons for delayed registration, and an editorial statement explaining the exception.

The Editor-in-Chief retains responsibility for the final editorial decision, independently of any financial or institutional considerations.

6. Reporting Standards

Randomized controlled trials should comply with the applicable CONSORT reporting guidelines and relevant extensions, including those for cluster randomized trials.

Authors may be required to submit the study protocol, statistical analysis plan, participant flow diagram, and other supporting documentation for editorial or peer-review assessment.

The Editorial Office may compare registered outcomes with those reported in the manuscript and request explanations for discrepancies, amendments, or deviations from the original protocol.

7. Previously Published Articles

Where a potential registration omission is identified in an article published before the effective date of this policy, the Editorial Office will undertake a case-by-case assessment.

The assessment may consider the circumstances of the omission, the applicable editorial requirements at the time of submission, available study documentation, and whether additional concerns affect the reliability of the published findings.

Where appropriate, PESSR may issue a correction, Editorial Notice, or other post-publication statement to clarify the publication record.

Such notices do not constitute prospective trial registration, and the absence of registration cannot be retrospectively remedied by changing the original registration date.

Further editorial action may be considered where justified by the evidence, in accordance with the journal's publication ethics and post-publication correction policies.

8. Editorial Responsibility and Implementation

Authors are responsible for identifying whether their research meets the definition of a clinical trial and for completing appropriate registration.

Editors and reviewers are responsible for verifying the reported registration information and evaluating its consistency with the manuscript.

PESSR will incorporate clinical trial registration checks into its initial editorial screening, author guidelines, and applicable manuscript reporting requirements.

Effective date: To be specified and publicly announced by the Editorial Office.