Trial Registration Policy

Intercontinental Journal of Emergency Medicine (ICJEM) supports prospective registration of clinical trials in accordance with the recommendations of the International Committee of Medical Journal Editors (ICMJE).

For the purposes of this policy, a clinical trial is defined as a research project that prospectively assigns individuals or groups of individuals to one or more health-related interventions in order to evaluate the effects of those interventions on health-related outcomes.

Prospective Trial Registration

All clinical trials submitted to ICJEM must be registered in a publicly accessible clinical trial registry before or at the time of first participant consent or enrollment.

Registration performed only after participant enrollment has begun or at the time of manuscript submission is considered retrospective registration and does not normally satisfy the Journal's requirements.

Acceptable registries include:

• ClinicalTrials.gov; and
• Primary registries participating in the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP).

The trial record must be publicly accessible and contain the minimum registration information required by the relevant registry.

Approval by an ethics committee, institutional review board, or other regulatory authority does not replace the requirement for prospective clinical trial registration.

Registration Information in the Manuscript

For manuscripts reporting clinical trial results, authors must provide:

• Name of the trial registry;
• Trial registration number;
• Date of registration; and
• Date of first participant enrollment.

The registration number should be stated at the end of the abstract and in the Methods section.

Where applicable, authors should also provide a direct link to the publicly accessible trial registration record.

The information reported in the manuscript should be consistent with the information contained in the trial registry. Any material changes to the study protocol, primary or secondary outcomes, eligibility criteria, sample size, intervention, or statistical analysis plan made after registration must be transparently reported and justified.

Late or Retrospective Registration

ICJEM expects prospective registration of clinical trials.

Manuscripts describing trials that were not prospectively registered may be considered only in exceptional circumstances at the discretion of the Editorial Board.

In such cases, authors must:

• Register the trial before manuscript evaluation proceeds;
• Provide a detailed explanation for the delayed registration;
• Disclose the date of registration and the reason for the delay in the manuscript; and
• Provide any additional documentation requested by the Editorial Board.

Acceptance of a retrospectively registered trial is not guaranteed. The Editorial Board may reject a manuscript when delayed registration raises concerns regarding selective reporting, outcome modification, or research integrity.

Clinical Trial Data Sharing Policy

Manuscripts reporting the results of clinical trials must include a Data Sharing Statement.

The Data Sharing Statement must clearly indicate:

• Whether de-identified individual participant data will be shared;
• Which specific data will be made available;
• Whether additional study materials will be shared, including study protocols, statistical analysis plans, data dictionaries, analytic code, or related documents;
• When the data will become available;
• How long the data will remain available;
• Who will be permitted to access the data;
• For what purposes or types of analyses the data may be used; and
• The mechanism by which access to the data may be requested or obtained.

A statement indicating that the authors are “undecided” regarding data sharing is not acceptable.

Clinical trials that began enrolling participants on or after January 1, 2019 should include a data sharing plan in the trial registration record. If the data sharing plan is modified after registration, the change should be reflected both in the trial registry and in the Data Sharing Statement included with the manuscript.

Authors are not necessarily required to make all clinical trial data publicly available. Where sharing is restricted because of patient confidentiality, privacy, informed consent limitations, ethical restrictions, legal requirements, contractual obligations, or other legitimate reasons, these restrictions must be clearly explained.

Where data are deposited in an appropriate repository, authors should provide a persistent identifier, such as a DOI, accession number, or permanent repository link.

Secondary Analyses of Shared Clinical Trial Data

Manuscripts based on secondary analyses of previously shared clinical trial data must:

• Identify and appropriately cite the original dataset;
• Provide the persistent identifier of the dataset where available;
• Confirm that the data were used in accordance with the applicable terms of access;
• Clearly describe how the secondary analysis differs from previously published analyses of the same dataset; and
• Appropriately acknowledge the investigators and institutions responsible for generating the original data.

Compliance

Compliance with trial registration requirements does not replace the need for ethics committee approval, informed consent, adherence to the appropriate reporting guideline, or compliance with other ICJEM editorial and publication ethics policies.

The Editorial Board reserves the right to verify trial registration records, request protocol documents and statistical analysis plans, and investigate discrepancies between the registry record and the submitted manuscript.