Common Data Models Harmonization
1.0.0 - STU 1 Publication

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## Resource Profile: CdmhResearchStudy - Detailed Descriptions

Definitions for the cdmh-researchstudy resource profile.

1. ResearchStudy
Definition | Sets expectations for supported capabilities for ResearchStudy resource in CDMH IG.
Control | 0..*
Alternate Names | Clinical Trial, Study
Comments | Need to make sure we encompass public health studies.
Invariants | Defined on this element dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty()) dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (: text.`div`.exists())
2. ResearchStudy.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Control | 0..1
Type | string
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
3. ResearchStudy.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Control | 0..1
Type | Meta
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. ResearchStudy.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Control | 0..1
Type | uri
Is Modifier | true
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. ResearchStudy.language
Definition | The base language in which the resource is written.
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages Max Binding: AllLanguages A human language.
Type | code
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. ResearchStudy.text
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Control | 0..1
Type | Narrative
Alternate Names | narrative, html, xhtml, display
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. ResearchStudy.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Control | 0..*
Type | Resource
Alternate Names | inline resources, anonymous resources, contained resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
8. ResearchStudy.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
9. ResearchStudy.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Control | 0..*
Type | Extension
Is Modifier | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. ResearchStudy.identifier
Definition | Identifiers assigned to this research study by the sponsor or other systems.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. ResearchStudy.title
Definition | A short, descriptive user-friendly label for the study.
Control | 0..1
Type | string
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. ResearchStudy.protocol
Definition | The set of steps expected to be performed as part of the execution of the study.
Control | 0..*
Type | Reference(PlanDefinition)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. ResearchStudy.partOf
Definition | A larger research study of which this particular study is a component or step.
Control | 0..*
Type | Reference(ResearchStudy)
Requirements | Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Alternate Names | container
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. ResearchStudy.status
Definition | The current state of the study.
Control | 1..1
Binding | The codes SHALL be taken from ResearchStudyStatus Codes that convey the current status of the research study.
Type | code
Is Modifier | true
Must Support | true
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. ResearchStudy.primaryPurposeType
Definition | The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Control | 0..1
Binding | The codes SHALL be taken from ResearchStudyPrimaryPurposeType; other codes may be used where these codes are not suitable Codes for the main intent of the study.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. ResearchStudy.phase
Definition | The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Control | 0..1
Binding | For example codes, see ResearchStudyPhase Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. ResearchStudy.category
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Control | 0..*
Binding | Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. ResearchStudy.focus
Definition | The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Control | 0..*
Binding | Codes for medications, devices and other interventions.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. ResearchStudy.condition
Definition | The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
Control | 0..*
Binding | For example codes, see Condition/Problem/DiagnosisCodes Identification of the condition or diagnosis.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. ResearchStudy.contact
Definition | Contact details to assist a user in learning more about or engaging with the study.
Control | 0..*
Type | ContactDetail
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. ResearchStudy.relatedArtifact
Definition | Citations, references and other related documents.
Control | 0..*
Type | RelatedArtifact
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. ResearchStudy.keyword
Definition | Key terms to aid in searching for or filtering the study.
Control | 0..*
Binding | Words associated with the study that may be useful in discovery.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. ResearchStudy.location
Definition | Indicates a country, state or other region where the study is taking place.
Control | 0..*
Binding | The codes SHALL be taken from Jurisdiction ValueSet; other codes may be used where these codes are not suitable Countries and regions within which this artifact is targeted for use.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. ResearchStudy.description
Definition | A full description of how the study is being conducted.
Control | 0..1
Type | markdown
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. ResearchStudy.enrollment
Definition | Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes".
Control | 0..*
Type | Reference(CdmhGroup)
Must Support | true
Alternate Names | patient
Comments | The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. ResearchStudy.period
Definition | Identifies the start date and the expected (or actual, depending on status) end date for the study.
Control | 0..1
Type | Period
Alternate Names | timing
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. ResearchStudy.sponsor
Definition | An organization that initiates the investigation and is legally responsible for the study.
Control | 0..1
Type | Reference(Organization)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
28. ResearchStudy.principalInvestigator
Definition | A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.
Control | 0..1
Type | Reference(Practitioner | PractitionerRole)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
29. ResearchStudy.site
Definition | A facility in which study activities are conducted.
Control | 0..*
Type | Reference(Location)
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. ResearchStudy.reasonStopped
Definition | A description and/or code explaining the premature termination of the study.
Control | 0..1
Binding | For example codes, see ResearchStudyReasonStopped Codes for why the study ended prematurely.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. ResearchStudy.note
Definition | Comments made about the study by the performer, subject or other participants.
Control | 0..*
Type | Annotation
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. ResearchStudy.arm
Definition | Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.
Control | 0..*
Type | BackboneElement
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. ResearchStudy.arm.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Control | 0..1
Type | string
34. ResearchStudy.arm.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
35. ResearchStudy.arm.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Control | 0..*
Type | Extension
Is Modifier | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
36. ResearchStudy.arm.name
Definition | Unique, human-readable label for this arm of the study.
Control | 1..1
Type | string
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. ResearchStudy.arm.type
Definition | Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
Control | 0..1
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. ResearchStudy.arm.description
Definition | A succinct description of the path through the study that would be followed by a subject adhering to this arm.
Control | 0..1
Type | string
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. ResearchStudy.objective
Definition | A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
Control | 0..*
Type | BackboneElement
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. ResearchStudy.objective.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Control | 0..1
Type | string
41. ResearchStudy.objective.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
42. ResearchStudy.objective.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Control | 0..*
Type | Extension
Is Modifier | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
43. ResearchStudy.objective.name
Definition | Unique, human-readable label for this objective of the study.
Control | 0..1
Type | string
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. ResearchStudy.objective.type
Definition | The kind of study objective.
Control | 0..1
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType Codes for the kind of study objective.
Type | CodeableConcept
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))