Table 1 Listing of the 20 WHO items for clinical study protocol
From: Towards achieving semantic interoperability of clinical study data with FHIR
WHO trial registration data set | PlanDefinition | ClinicalStudyPlan |
|---|---|---|
1. Primary registry and trial identifying number | Identifier | Identifier |
2. Date of registration in primary registry | Â | RegistrationDate |
3. Secondary identifying numbers | Identifier | ExternalIdentifier |
4. Source(s) of monetary or material support | Â | Â |
5. Primary sponsor | Â | Sponsor |
6. Secondary sponsor(s) | Â | Sponsor |
7. Contact for public queries | Publisher | PublicContact |
8. Contact for scientific queries | Â | Investigator |
9. Public title | Title | Title |
10. Scientific title | Â | OfficialTitle |
11. Countries of recruitment | Â | Â |
12. Health condition(s) or problem(s) studied | Purpose* | Description |
13. Intervention(s) | ActionDefinition | Activity |
14. Key inclusion and exclusion criteria | Â | Â |
15. Study type | Type* | * |
16. Date of first enrolment | Â | DateFirstEnrolment |
17. Target sample size | Â | SampleSize |
18. Recruitment status | Status | Status |
19. Primary outcome(s) | Coverage* | Goal |
20. Key secondary outcomes | Coverage* | Goal |