Last Updated: December 12, 2024
SECTION 1: REGISTRATION POLICY
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1. Mandatory Registration
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□ Required for:
- All clinical trials (phases I-IV)
- Interventional studies
- Observational studies with prospective data collection
- Systematic reviews/meta-analyses (PROSPERO)
- Post-marketing surveillance studies
2. Timing of Registration
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□ Requirements:
- Prior to first participant enrollment
- Before submission to journal
- Updates throughout trial conduct
- Results posting within 12 months of completion
SECTION 2: APPROVED REGISTRIES
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1. Primary Registries
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□ Acceptable registries:
- ClinicalTrials.gov
- WHO International Clinical Trials Registry Platform (ICTRP)
- EU Clinical Trials Register
- ISRCTN Registry
- Australian New Zealand Clinical Trials Registry (ANZCTR)
- Clinical Trials Registry - India (CTRI)
2. Registry Requirements
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□ Must provide:
- Unique trial identifier
- Public accessibility
- Free access
- Searchable database
- Results posting capability
SECTION 3: REGISTRATION INFORMATION
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1. Minimum Dataset
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□ Required elements:
- Trial identification number
- Protocol version and date
- Funding source(s)
- Primary sponsor
- Secondary sponsor(s)
- Principal investigator
- Research contact person
- Study title (scientific and public)
- Study design and methodology
- Intervention(s)
- Key inclusion/exclusion criteria
- Primary and secondary outcomes
- Target sample size
- Recruitment status
- Study start and completion dates
2. Additional Information
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□ Recommended elements:
- Data monitoring committee details
- Interim analyses plan
- Early stopping rules
- Safety monitoring procedures
- Dissemination plan
SECTION 4: SUBMISSION REQUIREMENTS
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1. Manuscript Submission
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□ Authors must provide:
- Trial registration number
- Registry name
- URL of trial registry record
- Date of registration
- Stage of trial at registration
2. Documentation Verification
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□ Editorial office checks:
- Validity of registration
- Completeness of registry record
- Consistency with manuscript
- Timing of registration
SECTION 5: RESULTS REPORTING
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1. Results Posting
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□ Requirements:
- Primary outcome results within 12 months
- Secondary outcome results within 24 months
- Adverse events reporting
- Protocol amendments
- Full dataset availability statement
2. Publication Requirements
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□ Must include:
- CONSORT statement compliance
- Protocol deviations reporting
- Negative results reporting
- Data sharing plan
SECTION 6: COMPLIANCE AND ENFORCEMENT
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1. Non-compliance Consequences
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□ Actions for:
- Unregistered trials
- Late registration
- Incomplete registration
- Missing results
- Inconsistent information
2. Resolution Process
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□ Steps include:
- Author notification
- Correction opportunity
- Registration verification
- Editorial decision
SECTION 7: SPECIAL CONSIDERATIONS
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1. International Trials
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□ Requirements for:
- Multiple registry entries
- Cross-referencing
- Language considerations
- Local regulations compliance
2. Protocol Changes
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□ Guidelines for:
- Amendment documentation
- Registry updates
- Version control
- Change justification
APPENDIX A: REGISTRATION CHECKLIST
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1. Pre-registration
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□ Required items:
- Protocol finalization
- Ethics committee approval
- Funding confirmation
- Sponsor agreements
2. During Trial
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□ Monitoring items:
- Recruitment updates
- Protocol modifications
- Safety reports
- Interim analyses
3. Post-completion
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□ Final items:
- Results posting
- Publication submission
- Data sharing
- Archive maintenance
Note: This policy aligns with COPE (Committee on Publication Ethics) guidelines,
International Committee of Medical Journal Editors (ICMJE) requirements, and
World Health Organization (WHO) standards for clinical trial transparency.