Table 3.
Comparison of key characteristics of reviewed information models
| Aspect | CTOM version 1.3 (2007) | PCROM version 2.0 | BRIDG (version 3.02) PR sub-domain | CDISC SDM version 1.0 | HL7 RIM 2.41 | EHR RM, 1.02 | Comment |
|---|---|---|---|---|---|---|---|
| Basic concepts | Activity, study event | Activity, study event | Study activity | Activity, study event | Entity, Role, Participation, Acts | Care_entry, admin_entry, instruction, activity | Differences with respect to relation between activity and study event |
| Representation of structural concepts of clinical trials | Study time point | Epoch | Epoch, cell, segment | A medical record is a record of each of the individual actions that make up the diagnosis, treatment and care of a patient | Through observation, history, event | Differences in granularity, in some cases indirect representation | |
| Link to study protocol | From activity via study participant via site to protocol | From study event via period via timeline to protocol | From study activity to sub-protocol version | Protocol elements exist within categories: structure, workflow, timing | Different concepts (link via patient, standard elements of protocol) | ||
| Representation of care aspects | Health care site, health care site participant | Health care site, patient | Health care provider (subject) | SubstanceAdminis-tration, PatientEncounter, DiagnosticImage | Care_entry, event_con-text | Represented, except for CDISC SDM |
PR = Protocol Representation, SDM = Study Design Model.