Table 3.
Areas in which existing standards overlap with the context of collection concept
| Proposed concept | Relevant HL7 FHIR resources | Relevant CDISC PRM/SDTM/SDTMIG-MD domains | Relevant W3C SOSA and SSNO modules | Relevant Open mHealth schemas |
|---|---|---|---|---|
| Context of collection | ResearchStudy | Trial design (model) | Procedure | Activity name |
| ResearchDefinition | Trial inclusion criteria | Ambient temperature | ||
| Goal | Trial summary | Geoposition | ||
| Procedure | Subject visits and elements | Sleep duration | ||
| Location | Procedures | Sleep episode | ||
| Device | Protocol deviations | |||
| Encounter | Study device identifiers | |||
| DetectedIssue | Device events | |||
| Condition |
CDISC, Clinical Data Interchange Standards Consortium; FHIR, Fast Healthcare Interoperable Resources; HL7, Health Level 7; PRM, Protocol Representation Model; SDTM, Study Data Tabulation Model; SDTMIG-MD, Study Data Tabulation Model Implementation Guide for Medical Devices; SOSA, Sensor, Observation, Sample, and Actuator; SSNO, Semantic Sensor Network Ontology.