Clinical Trial Registration Policy

1. Scope of this Policy

This policy applies to clinical trials and other prospective interventional studies involving human participants where one or more health-related interventions are assigned to evaluate effects on health outcomes.

• drug, biologic, vaccine, and device trials
• surgical or procedural intervention studies
• behavioral, dietary, exercise, educational, or public health interventions with health outcomes
• other prospectively assigned interventional clinical research as defined by accepted registry standards

2. Registration Requirement

SIARE requires that eligible clinical trials be registered in a publicly accessible trial registry before the first participant is recruited or enrolled, as a condition of full ethical and editorial compliance. This aligns with ICMJE’s requirement for registration at or before first participant enrollment and with the Declaration of Helsinki principle that every clinical trial should be registered in a publicly accessible database before recruitment of the first subject. :contentReference[oaicite:1]{index=1}

3. Acceptable Registries

Trials should be registered in a recognized public registry that supports public access, persistent trial records, and internationally acceptable registration practices. SIARE expects registration in registries that are part of, linked to, or otherwise consistent with the WHO International Clinical Trials Registry Platform (ICTRP) ecosystem, or in other widely recognized public registries accepted by editorial policy. WHO notes that ICTRP itself is not a registry, but a platform connecting recognized registries. :contentReference[oaicite:2]{index=2}

• The registry must be publicly searchable
• The trial record must remain accessible
• The registry should provide a unique registration identifier
• Registered information should be sufficiently complete for public transparency

4. Information Required in the Manuscript

Authors must provide clear trial registration information in the manuscript and submission metadata where applicable.

• Name of the trial registry
• Trial registration number or identifier
• Date of registration where relevant
• Confirmation that registration occurred before first participant enrollment, if applicable

The registration information should be reported consistently across the manuscript, abstract where required, and submission system records.

5. Consistency Between Registry and Manuscript

Editors may check whether the manuscript is consistent with the public trial registration record. Major unexplained discrepancies may trigger clarification or further ethics review.

• Trial title and objective should align with the registry record
• Interventions and participant population should be consistent
• Primary endpoints or main study outcomes should not be misleadingly altered without explanation
• Trial status and study dates should be reasonably coherent with the submission

6. Late Registration and Non-Registration

If a trial was registered after participant enrollment began, or was not registered at all, authors must provide a clear explanation. SIARE may evaluate the seriousness of the non-compliance in light of ethical standards, editorial policy, and the reliability of the record.

• Late registration must be disclosed transparently
• Absence of registration may affect publication eligibility
• Serious or unjustified non-compliance may lead to rejection

7. Clinical Trial Reporting and Transparency

Trial registration is part of a broader transparency framework. Authors are expected to report clinical trials responsibly and in a manner consistent with recognized reporting standards and ethical requirements. ClinicalTrials.gov also notes that ICMJE registration policy is widely followed by journals. :contentReference[oaicite:3]{index=3}

• Trial methods and outcomes should be reported clearly
• Ethical approval and informed consent requirements must be satisfied
• Protocol deviations or major changes should be handled transparently
• Reporting guidelines such as CONSORT should be followed where relevant

8. Relationship to Human Subjects and Consent Policies

Clinical trial registration does not replace ethics approval or informed consent. Authors must also comply with SIARE’s policies on human participants, clinical research, informed consent, conflicts of interest, data transparency, and misconduct handling.

9. Editorial Verification and Compliance Review

Editors may verify clinical trial registration details during editorial screening, peer review, or pre-publication checks. Where necessary, authors may be asked to provide clarification or supporting information.

• Editors may review registry timing and public record status
• Authors may be asked to explain discrepancies or delays
• Serious concerns may be escalated under ethics and misconduct procedures

10. Post-Publication Concerns

If significant problems relating to trial registration are discovered after publication, SIARE may take corrective action to protect the scholarly record.

• Request clarification or documentation from authors
• Issue a correction or editorial note where appropriate
• Consider expression of concern, withdrawal, or retraction in serious cases

11. External Standards and Guidance

This policy is informed by leading international guidance on clinical trial registration and transparency.

• ICMJE Clinical Trial Registration Recommendations
• WHO International Clinical Trials Registry Platform (ICTRP)
• WHO Trial Registration Guidance
• Declaration of Helsinki
• ClinicalTrials.gov Reporting and Registration Guidance

12. Related Policies

• Human Subjects & Clinical Research Policy
• Informed Consent Policy
• Ethics & Compliance Requirements
• Data & Reproducibility Policy
• Handling Misconduct
• Publication Ethics