Clinical Study Schedule of Activities
1.0.0 - trial-use International flag

Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

Profiles

SoA Resource Profiles

The following profiles are defined for exchanging study schedule information.

Resource Profile Name Profile Description
ResearchStudy ResearchStudySoa A profile that lists the data elements of a Research Study that must be supported when used to schedule activities.
PlanDefinition StudyProtocolSoa A profile that lists the data elements of a PlanDefinition that must be supported so that it can represent an entire set of visits and activities for a given study protocol.
PlanDefinition StudyVisitSoa An abstract profile that lists the data elements of a PlanDefinition that must be supported so that it can represent a Study Visit.
PlanDefinition PlannedStudyVisitSoa A profile that further qualifies the StudyVisitSoa profile so that it can represent a planned visit.
ActivityDefinition StudyActivitySoa A profile lists the data elements of an ActivityDefinition that must be supported so that it can represent an activity that is being scheduled.

Extensions

The following extensions are defined to enable data elements that are not currently present in the core resources.

Extension Context Description
AcceptableOffsetRange PlanDefinition.action.relatedAction Provides an offset range that, along with offsetDuration, indicates an acceptable range of dates for a related action, i.e. +10-15 days

Global Profiles

There are no Global profiles defined

IG Dependencies

This IG Contains the following dependencies on other IGs.

IGPackageFHIRComment
.. Clinical Study Schedule of Activitieshl7.fhir.uv.vulcan-schedule#1.0.0R4
... HL7 Terminology (THO)hl7.terminology.r4#5.0.0R4Automatically added as a dependency - all IGs depend on HL7 Terminology

Cross-Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.uv.vulcan-schedule.r4) and R4B (hl7.fhir.uv.vulcan-schedule.r4b) are available.

Intellectual Property Statements

This publication includes IP covered under the following statements.