| ICMJE/WHO Minimal Registration Data Set | ClinicalTrials.gov Data Element(s) |
|---|---|
| 1. Unique trial number - assigned | Unique Identifier (NCT #) - assigned by system |
| 2. Trial registration date | First Received Date - assigned by system |
| 3. Secondary IDs - may be none | Organization's Protocol ID Number; Secondary Protocol ID Number(s) |
| 4. Funding sources(s) | Study Sponsor; Collaborators |
| 5. Primary sponsor | Study Sponsor |
| 6. Secondary sponsor(s) - may be none | Collaborators |
| 7. Responsible contact person | Facility Contact Information (or Central); Central Contact for All Trial Sites (or per Facility) |
| 8. Research contact person | Overall Study Official(s) |
| 9. Title of the study - optional | Brief Title (lay language) |
| 10. Official scientific title of the study | Official Title |
| 11. Research ethics review (yes/no) | Human Subjects Review Approval? (yes/no) |
| 12. Condition | Condition(s) |
| 13. Intervention(s) - generic/company serial number | Intervention: Type/Name |
| 14. Key inclusion and exclusion criteria | Eligibility Criteria |
| 15. Study type | Study Type (Interventional/Observational); Study Design |
| 16. Anticipated trial start date | Start Date |
| 17. Target sample size | Target Number of Subjects |
| 18. Recruitment status (yes/no) | Overall Recruitment Status |
| 19. Primary outcome | Primary Outcome Measure(s) |
| 20. Key secondary outcomes | Secondary Outcome Measure(s) |