R6 Checklist for ResearchStudy

Artifact ResearchStudy (ResearchStudy)

Urgent Item Checklist

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All Analysis Information

The following content was generated to assist in the review of this artifact for R6 compliance.

Information Page

General Information:

Page File Name	`researchstudy-introduction.xml`
Responsible Workgroup	`brr`
Maturity Label	`Draft`
Maturity Level	`0`
Standards Status	`trial-use`
Management Comments
Workgroup Comments
Exists In `publish.ini`	`No`
Exists In Source Directory	`Yes`
'`deprecated`' Literal Count	`0`
Zulip Link Count	`0`
Confluence Link Count	`0`

Conformance Language Summary

'Conformant' conformance language appears in all-upper case. 'Non-conformant' covers all other cases appearing in the content.

Literal	Conformant	Non-Conformant
SHALL	0	0
SHALL NOT	0	0
SHOULD	0	1
SHOULD NOT	0	0
MAY	0	0
MAY NOT	0	0

Possibly Removed FHIR Artifact Literals Found on Page

Word	Artifact Class

Unknown Words Found on Page

Word	Known Typo
`Proteomic`	No
`SiteRecruitment`	No
`StudyRegistration`	No
`clinicaltrials.gov`	No

Images with Issues

Source	Missing Alt Text	Not In Figure Tag

Possible Incomplete Markers Found on Page

Reader Review Notes Found on Page

Balloters

Notes Page

General Information:

Page File Name	`researchstudy-notes.xml`
Responsible Workgroup	`brr`
Maturity Label	`Draft`
Maturity Level	`0`
Standards Status	`trial-use`
Management Comments
Workgroup Comments
Exists In `publish.ini`	`No`
Exists In Source Directory	`Yes`
'`deprecated`' Literal Count	`0`
Zulip Link Count	`0`
Confluence Link Count	`0`

Conformance Language Summary

'Conformant' conformance language appears in all-upper case. 'Non-conformant' covers all other cases appearing in the content.

Literal	Conformant	Non-Conformant
SHALL	0	0
SHALL NOT	0	0
SHOULD	0	0
SHOULD NOT	0	0
MAY	0	0
MAY NOT	0	0

Possibly Removed FHIR Artifact Literals Found on Page

Word	Artifact Class

Unknown Words Found on Page

Word	Known Typo

Images with Issues

Source	Missing Alt Text	Not In Figure Tag
`researchstudy-state-machine.png`	No	Yes

Possible Incomplete Markers Found on Page

Reader Review Notes Found on Page

Element Review

Path	Is Required	Not Array	Required Binding	Check `meaningWhenMissing`	Is Modifier
`ResearchStudy`		X
`ResearchStudy.url`
`ResearchStudy.identifier`		X
`ResearchStudy.version`
`ResearchStudy.name`
`ResearchStudy.title`
`ResearchStudy.label`		X
`ResearchStudy.label.type`
`ResearchStudy.label.value`
`ResearchStudy.label.language`			optional - NO 'other' or 'unknown'	X
`ResearchStudy.protocol`		X
`ResearchStudy.partOf`		X
`ResearchStudy.citeAs`
`ResearchStudy.relatesTo`		X
`ResearchStudy.relatesTo.type`	X
`ResearchStudy.relatesTo.target[x]`	X
`ResearchStudy.date`
`ResearchStudy.status`	X		Has 'unknown'		X
`ResearchStudy.primaryPurposeType`
`ResearchStudy.phase`
`ResearchStudy.studyDesign`		X
`ResearchStudy.focus`		X
`ResearchStudy.condition`		X
`ResearchStudy.keyword`		X
`ResearchStudy.region`		X
`ResearchStudy.descriptionSummary`
`ResearchStudy.description`
`ResearchStudy.period`
`ResearchStudy.site`		X
`ResearchStudy.note`		X
`ResearchStudy.classifier`		X
`ResearchStudy.associatedParty`		X
`ResearchStudy.associatedParty.name`
`ResearchStudy.associatedParty.role`	X
`ResearchStudy.associatedParty.period`		X
`ResearchStudy.associatedParty.classifier`		X
`ResearchStudy.associatedParty.party`
`ResearchStudy.progressStatus`		X
`ResearchStudy.progressStatus.state`	X
`ResearchStudy.progressStatus.actual`				X
`ResearchStudy.progressStatus.period`
`ResearchStudy.whyStopped`
`ResearchStudy.recruitment`
`ResearchStudy.recruitment.targetNumber`
`ResearchStudy.recruitment.actualNumber`
`ResearchStudy.recruitment.eligibility`
`ResearchStudy.recruitment.actualGroup`
`ResearchStudy.recruitment.description`
`ResearchStudy.comparisonGroup`		X
`ResearchStudy.comparisonGroup.targetNumber`
`ResearchStudy.comparisonGroup.actualNumber`
`ResearchStudy.comparisonGroup.eligibility`
`ResearchStudy.comparisonGroup.observedGroup`
`ResearchStudy.comparisonGroup.description`
`ResearchStudy.objective`		X
`ResearchStudy.objective.name`
`ResearchStudy.objective.type`
`ResearchStudy.objective.description`
`ResearchStudy.objective.outcomeMeasure`		X
`ResearchStudy.objective.outcomeMeasure.name`
`ResearchStudy.objective.outcomeMeasure.type`
`ResearchStudy.objective.outcomeMeasure.description`
`ResearchStudy.objective.outcomeMeasure.endpoint`	X
`ResearchStudy.objective.outcomeMeasure.population`
`ResearchStudy.objective.outcomeMeasure.intervention`
`ResearchStudy.objective.outcomeMeasure.comparator`
`ResearchStudy.objective.outcomeMeasure.summaryMeasure`
`ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan`
`ResearchStudy.objective.outcomeMeasure.eventHandling`		X
`ResearchStudy.objective.outcomeMeasure.eventHandling.event`
`ResearchStudy.objective.outcomeMeasure.eventHandling.group`
`ResearchStudy.objective.outcomeMeasure.eventHandling.handling`
`ResearchStudy.objective.outcomeMeasure.eventHandling.description`
`ResearchStudy.result`		X

Operations

No operations found.

Search Parameters

Id	Name	Publication Status	Standards Status	IsExperimental	WorkGroup	Search Type	Description
`ResearchStudy-classifier`	`classifier`	Draft	trial-use	False	brr	token	Classification for the study
`ResearchStudy-condition`	`condition`	Draft	trial-use	False	brr	token	Condition being studied
`ResearchStudy-date`	`date`	Draft	trial-use	False	brr	date	When the study began and ended
`ResearchStudy-description`	`description`	Draft	trial-use	False	brr	string	Detailed narrative of the study
`ResearchStudy-eligibility`	`eligibility`	Draft	trial-use	False	brr	reference	Inclusion and exclusion criteria
`ResearchStudy-focus-code`	`focus-code`	Draft	trial-use	False	brr	token	Drugs, devices, etc. under study, as a code
`ResearchStudy-focus-reference`	`focus-reference`	Draft	trial-use	False	brr	reference	Drugs, devices, etc. under study, as a reference
`ResearchStudy-identifier`	`identifier`	Draft	trial-use	False	brr	token	Business Identifier for study
`ResearchStudy-keyword`	`keyword`	Draft	trial-use	False	brr	token	Used to search for the study
`ResearchStudy-name`	`name`	Draft	trial-use	False	brr	string	Name for this study
`ResearchStudy-objective-description`	`objective-description`	Draft	trial-use	False	brr	string	Free text description of the objective of the study
`ResearchStudy-objective-type`	`objective-type`	Draft	trial-use	False	brr	token	The kind of study objective
`ResearchStudy-part-of`	`part-of`	Draft	trial-use	False	brr	reference	Part of larger study
`ResearchStudy-phase`	`phase`	Draft	trial-use	False	brr	token	The stage in the progression of a study
`ResearchStudy-progress-actual`	`progress-actual`	Draft	trial-use	False	brr	token	Actual if true else anticipated
`ResearchStudy-progress-period`	`progress-period`	Draft	trial-use	False	brr	date	Date range
`ResearchStudy-progress-state`	`progress-state`	Draft	trial-use	False	brr	token	Label for status or state
`ResearchStudy-progress-status-state-actual`	`progress-status-state-actual`	Draft	trial-use	False	brr	composite	Status of study by state and actual
`ResearchStudy-progress-status-state-period`	`progress-status-state-period`	Draft	trial-use	False	brr	composite	Status of study by state and period
`ResearchStudy-progress-status-state-period-actual`	`progress-status-state-period-actual`	Draft	trial-use	False	brr	composite	Status of study by state, period and actual
`ResearchStudy-protocol`	`protocol`	Draft	trial-use	False	brr	reference	Steps followed in executing study
`ResearchStudy-recruitment-actual`	`recruitment-actual`	Draft	trial-use	False	brr	number	Actual number of participants enrolled in study across all groups
`ResearchStudy-recruitment-target`	`recruitment-target`	Draft	trial-use	False	brr	number	Target number of participants enrolled in study across all groups
`ResearchStudy-region`	`region`	Draft	trial-use	False	brr	token	Geographic area for the study
`ResearchStudy-site`	`site`	Draft	trial-use	False	brr	reference	Facility where study activities are conducted
`ResearchStudy-status`	`status`	Draft	trial-use	False	brr	token	active \| active-but-not-recruiting \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| enrolling-by-invitation \| in-review \| not-yet-recruiting \| recruiting \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| terminated \| withdrawn
`ResearchStudy-study-design`	`study-design`	Draft	trial-use	False	brr	token	Classifications of the study design characteristics
`ResearchStudy-title`	`title`	Draft	trial-use	False	brr	string	The human readable name of the research study