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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   RegistrationDate
3. Secondary identifying numbers Identifier ExternalIdentifier
4. Source(s) of monetary or material support   
5. Primary sponsor   Sponsor
6. Secondary sponsor(s)   Sponsor
7. Contact for public queries Publisher PublicContact
8. Contact for scientific queries   Investigator
9. Public title Title Title
10. Scientific title   OfficialTitle
11. Countries of recruitment   
12. Health condition(s) or problem(s) studied Purpose* Description
13. Intervention(s) ActionDefinition Activity
14. Key inclusion and exclusion criteria   
15. Study type Type* *
16. Date of first enrolment   DateFirstEnrolment
17. Target sample size   SampleSize
18. Recruitment status Status Status
19. Primary outcome(s) Coverage* Goal
20. Key secondary outcomes Coverage* Goal
  1. An asterisk (‘*’) indicates that this data item is partially or indirectly addressed in the model