Clinical Trial Registration Policy

Clinical Trial Registration Policy

At ETFLIN, we are committed to promoting transparency, accountability, and ethical standards in biomedical research. In accordance with recommendations by the International Committee of Medical Journal Editors (ICMJE), the World Health Organization (WHO), and COPE guidelines, we require that all clinical trials submitted for publication in our journals be prospectively registered in a publicly accessible trial registry.

Definition of a Clinical Trial

A clinical trial is defined as any research study that prospectively assigns human participants or groups to one or more health-related interventions to evaluate the effects on health outcomes. Interventions may include drugs, surgical procedures, behavioral treatments, devices, preventive care, and more.

Acceptable Trial Registries

Clinical trials must be registered in a registry that is:

• Publicly accessible

• Managed by a non-profit organization

• Open to all registrants

• Identified by the WHO as a primary registry

Examples of acceptable registries include:

• ClinicalTrials.gov

• ISRCTN

• EU Clinical Trials Register

• Chinese Clinical Trial Registry

• Australian New Zealand Clinical Trials Registry (ANZCTR)

• Any WHO ICTRP-approved registry

For the full list of WHO-approved trial registries, visit WHO ICTRP.

Registration Timing

• Trials must be registered before the enrollment of the first participant.

• Submissions based on trials registered retrospectively may be considered but must include a justification for delayed registration, which will be evaluated by the editors. For more information, read COPE guideline for retrospective trial registration.

Required Information

At the time of manuscript submission, authors must:

• Provide the trial registration number

• Include the name of the registry

• Ensure the registry entry is publicly available and up to date

• Report any protocol amendments or deviations

Reporting Guidelines

Manuscripts describing clinical trials must follow CONSORT (Consolidated Standards of Reporting Trials) guidelines. A completed CONSORT checklist should be submitted along with the manuscript.

For more information: CONSORT Statement.

Non-compliance

Manuscripts failing to comply with this policy may be returned without review or rejected. Exceptions may be made at the discretion of the editors for justified reasons, which must be clearly explained by the authors.