NCPI-FHIR-IMPLEMENTATION-GUIDE\Study Summary

NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

Resource Profile: Study Summary

Official URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/study-summary				Version: 0.2.0
Draft as of 2022-12-09				Computable Name: StudySummary

An observation containing summary information about a study in it’s entirety or one of it’s subpopulations.

Key Guidelines

The Study Summary profile is based on the standard FHIR Observation and is intended to provide summary information across an entire study or subgroup of a particular study. The individual summary details are listed as part of the Observation’s component array.

Added Profile Restrictions

In order to clarify the contents of the summary observation, the code MUST include the UMLs code, C0242482, for Summary Report.
To ensure uniform usability, the subject MUST only reference NCPI Study Group.
Again to enforce uniform behavior, there MUST be at least one focus and that MUST be one of the NCPI Research Study resources.
Because the entire purpose of the summary are the contents of the components, there MUST be at least one component.

Recommended Practice

The Study Summary profile is designed to help differentiate the summary at the study level as opposed to summaries that the variable level. Information contained within these summaries would be the sort of information someone might need to see in order to determine if the study is suitable to their research needs at a very high, including the following types of information:

Listing of consent group or cohorts the study is comprised of
Total number of participants found across entire study
Total Number of samples found across entire study
Storage required for download of study’s data

Usage:

This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Observation

Name	Card.	Type	Description & Constraints
Observation	0..*	Observation	Measurements and simple assertions
code
coding	0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system	1..1	uri	Identity of the terminology system Fixed Value: https://uts.nlm.nih.gov/uts/umls
code	1..1	code	Symbol in syntax defined by the system Fixed Value: C0242482
display	1..1	string	Representation defined by the system Fixed Value: Summary Report
subject	0..1	Reference(NCPI Study Group)	Who and/or what the observation is about
focus	1..*	Reference(NCPI Research Study)	What the observation is about, when it is not about the subject of record
component	1..*	BackboneElement	Component results
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered \| preliminary \| final \| amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
coding	Σ	0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: https://uts.nlm.nih.gov/uts/umls
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C0242482
display		1..1	string	Representation defined by the system Fixed Value: Summary Report
subject	Σ	0..1	Reference(NCPI Study Group)	Who and/or what the observation is about
focus	Σ	1..*	Reference(NCPI Research Study)	What the observation is about, when it is not about the subject of record
component	Σ	1..*	BackboneElement	Component results
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Observation.status	required	ObservationStatus
Observation.code	example	LOINCCodes (a valid code from LOINC)
Observation.component.code	example	LOINCCodes (a valid code from LOINC)

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ALL extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Description & Constraints

Observation

C

0..*

Observation

Measurements and simple assertions

id

Σ

0..1

id

Logical id of this artifact

Terminology Bindings

Path

Conformance

ValueSet

Observation.language

preferred

CommonLanguages

Additional Bindings

Purpose

AllLanguages

Max Binding

Observation.status

required

ObservationStatus

Observation.category

preferred

ObservationCategoryCodes

Observation.code

example

LOINCCodes (a valid code from LOINC)

Observation.dataAbsentReason

extensible

DataAbsentReason

Observation.interpretation

extensible

ObservationInterpretationCodes

Observation.bodySite

example

SNOMEDCTBodyStructures

Observation.method

example

ObservationMethods

Observation.referenceRange.type

preferred

ObservationReferenceRangeMeaningCodes

Observation.referenceRange.appliesTo

example

ObservationReferenceRangeAppliesToCodes

Observation.component.code

example

LOINCCodes (a valid code from LOINC)

Observation.component.dataAbsentReason

extensible

DataAbsentReason

Observation.component.interpretation

extensible

ObservationInterpretationCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	ALL elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ALL extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()

This structure is derived from Observation

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from Observation

Name	Card.	Type	Description & Constraints
Observation	0..*	Observation	Measurements and simple assertions
code
coding	0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system	1..1	uri	Identity of the terminology system Fixed Value: https://uts.nlm.nih.gov/uts/umls
code	1..1	code	Symbol in syntax defined by the system Fixed Value: C0242482
display	1..1	string	Representation defined by the system Fixed Value: Summary Report
subject	0..1	Reference(NCPI Study Group)	Who and/or what the observation is about
focus	1..*	Reference(NCPI Research Study)	What the observation is about, when it is not about the subject of record
component	1..*	BackboneElement	Component results
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered \| preliminary \| final \| amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
code	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
coding	Σ	0..*	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: https://uts.nlm.nih.gov/uts/umls
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C0242482
display		1..1	string	Representation defined by the system Fixed Value: Summary Report
subject	Σ	0..1	Reference(NCPI Study Group)	Who and/or what the observation is about
focus	Σ	1..*	Reference(NCPI Research Study)	What the observation is about, when it is not about the subject of record
component	Σ	1..*	BackboneElement	Component results
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Observation.status	required	ObservationStatus
Observation.code	example	LOINCCodes (a valid code from LOINC)
Observation.component.code	example	LOINCCodes (a valid code from LOINC)

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ALL extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Snapshot View

Description & Constraints

Observation

C

0..*

Observation

Measurements and simple assertions

id

Σ

0..1

id

Logical id of this artifact

Terminology Bindings

Path

Conformance

ValueSet

Observation.language

preferred

CommonLanguages

Additional Bindings

Purpose

AllLanguages

Max Binding

Observation.status

required

ObservationStatus

Observation.category

preferred

ObservationCategoryCodes

Observation.code

example

LOINCCodes (a valid code from LOINC)

Observation.dataAbsentReason

extensible

DataAbsentReason

Observation.interpretation

extensible

ObservationInterpretationCodes

Observation.bodySite

example

SNOMEDCTBodyStructures

Observation.method

example

ObservationMethods

Observation.referenceRange.type

preferred

ObservationReferenceRangeMeaningCodes

Observation.referenceRange.appliesTo

example

ObservationReferenceRangeAppliesToCodes

Observation.component.code

example

LOINCCodes (a valid code from LOINC)

Observation.component.dataAbsentReason

extensible

DataAbsentReason

Observation.component.interpretation

extensible

ObservationInterpretationCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	ALL elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ALL extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()

This structure is derived from Observation

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Other representations of profile: CSV, Excel, Schematron

Notes:

IG © 2021+ NCPI FHIR Working Group. Package NCPI-FHIR-Implementation-Guide#0.2.0 based on FHIR 4.0.1. Generated 2022-12-09
Links: Table of Contents | QA Report