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

This page is part of the Clinical Study Schedule of Activities (v1.0.0: STU1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Artifacts Summary

Contents:

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Abstract Profiles

These are profiles on resources or data types that describe patterns used by other profiles, but cannot be instantiated directly. I.e. instances can conform to profiles based on these abstract profiles, but do not declare conformance to the abstract profiles themselves.

StudyVisitSoa

An abstract profile that lists the data elements of a PlanDefinition that must be supported so that it can represent a Study Visit.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

PlannedStudyVisitSoa

A profile that further qualifies the StudyVisitSoa profile so that it can represent a planned visit.
ResearchStudySoa

A profile that lists the data elements of a Research Study that must be supported when used to schedule activities.
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.
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.

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Acceptable Offset Range

Provides an offset range that, along with offsetDuration, indicates an acceptable range of dates for a related action.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Eli Lilly and Company

Sample Organization: Eli Lilly and Company
H2Q-MC-LZZT-ProtocolDesign

H2Q-MC-LZZT-Protocol Schedule of Activities
H2Q-MC-LZZT Research Study

Xanomeline (LY246708)

Protocol H2Q-MC-LZZT(c)

Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease
Visit-1

Planned Visit [Visit-1]
Visit-3

Planned Visit [Visit-3]
Vital Signs/Temperature

Planned Activity [Vital Signs]
Samuel Home, M.D.

Sample Practitioner: Samuel Home, M.D.