INTEROPen CareConnect Base STU3 Implementation Guide - Local Development build (v3.0.0). See the Directory of published versions
Mappings for the Profile.
| CareConnect-ResearchStudy-1 |
| ResearchStudy | Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN] |
| text | Act.text? |
| contained | N/A |
| extension | N/A |
| modifierExtension | N/A |
| identifier | .identifier |
| id | n/a |
| extension | n/a |
| use | Role.code or implied by context |
| type | Role.code or implied by context |
| system | II.root or Role.id.root |
| value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
| period | Role.effectiveTime or implied by context |
| assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
| protocol | .outboundRelationship[typeCode=DEFN].target |
| partOf | .inboundRelationship[typeCode=COMP].source[moodCode=EVN] |
| status | .status |
| note | |
| id | n/a |
| extension | n/a |
| author[x] | Act.participant[typeCode=AUT].role |
| time | Act.effectiveTime |
| text | Act.text |
| arm | |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| CareConnect-ResearchStudy-1 |
| ResearchStudy | |
| identifier | Organization's Unique Protocol ID; Secondary IDs |
| title | Brief Title |
| protocol | Interventions; Arm/Intervention Cross-Reference |
| category | Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention |
| focus | Conditions or Focus of Study |
| contact | Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators |
| relatedArtifact | Citations, Links, Available Study Data/Documents |
| keyword | Keywords |
| description | Detailed Description |
| enrollment | Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria) |
| period | Study Start Date (start); Study Completion Date (end) |
| sponsor | Sponsor |
| principalInvestigator | Principal Investigator |
| site | Facility |
| reasonStopped | Why Study Stopped |
| arm | Arms |
| name | Arm Label |
| code | Arm Type |
| description | Arm Description |