Protocols
Clinical protocols describe the design, conduct, and analysis plan for clinical studies before or during execution.
Clinical protocols describe the design, conduct, and analysis plan for clinical studies before or during execution.
When to select this type
Choose Clinical Protocol for interventional or clinical observational study plans.
Typical audience
Trialists, clinicians, regulators, and systematic reviewers.
Recommended use cases
Purpose
Enable transparency, registration, and reproducibility of clinical research.
Scope
Prospective clinical study protocols including trials and interventional studies.
Typical structure
Required sections
Recommended sections
Figures
0–3 study design or schedule figures.
Tables
1–4 for endpoints, visits, and outcomes.
References
15–50 references.
Supplementary material
Full SPIRIT checklist, consent templates, analysis code shells.
Required metadata
Required declarations
Funding requirements
Declare sponsors and their roles.
Conflict of interest
Disclose investigator and sponsor conflicts.
Ethics requirements
Ethics approval status and committee details required.
Consent requirements
Describe consent process and capacity assessments.
Data availability
State plans for sharing protocol amendments and results.
AI disclosure
Disclose AI use in protocol drafting or simulation.
Copyright
Authors retain copyright.
Licensing
Open access common for registered protocols.
Export formats supported
Promote complete and transparent clinical trial protocols before results are known.
Improve transparency and completeness of randomized trial reports so readers can assess validity and bias.
Typical journal expectations
SPIRIT checklist, registered trial ID, predefined endpoints.
Typical peer review process
Methodological review focused on design rigor and ethics.
Journal compatibility notes
Protocol journals and trial registries.
Submission readiness checklist
Select Clinical Protocol when your manuscript matches the scope, structure, and reporting expectations described on this page. If your work fits a different scholarly format, review similar publication types before submitting.
Contact the editorial team before payment if you need to change publication type. After editorial screening begins, type changes require editorial approval and may restart parts of the review process.
Reporting guidelines listed as recommended should be followed when applicable to your study design. Editorial reviewers assess completeness against the expectations for your selected publication type.
Platform standards for ethical research publication.
Transparent, ethical, and accountable AI use across research and publishing.
Transparency, independence, and responsible disclosure across research and publishing.