Generated Narrative: StructureDefinition m11-research-study-profile Name Flags Card. Type Description & Constraints ResearchStudy 0..* StudyDesign Investigation to increase healthcare-related patient-independent knowledge #xD; Slices for extension Content/Rules for all slices #xD; extension:narrative 0..* Reference(Research Study Narratives) Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements #xD; extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/protocol-amendment #xD; identifier #xD; type ?! 1..1 CodeableConcept Description of identifier Binding: M11 Identifier Type Value Set (extensible) #xD; coding #xD; code 1..1 code Symbol in syntax defined by the system #xD; label #xD; type 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: CDISC DDF Study Title Type Value Set (extensible) #xD; relatesTo #xD; type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes #xD; phase 0..1 CodeableConcept Classifier used for clinical trials Binding: M11 Phase Value Set (required) #xD; focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) Drugs, devices, etc. under study #xD; associatedParty #xD; role 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: NCI Study Role Value Set (extensible) #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
Constraint of ResearchStudy to M11 Guidance An instance of this profile represents a single version of the protocol definition. Previous amendments are represented by further instances of ResearchStudy linked through the relatedArtifact attribute.
Investigation to increase healthcare-related patient-independent knowledge
A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.
The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
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()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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.
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 its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
Contained resources do not have a 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.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
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. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional).
An individual or organization primarily involved in the creation and maintenance of the artifact.
Must have either extensions or value[x], not both
Resource (FHIR or non-FHIR) associated with the Resource, plus specification of a portion quoted from the Resource.
Sponsor Confidentiality Statement, if applicable.
Method for reporting Serious Adverse Events.
Report Serious Adverse Events to the sponsor. Enter SAE reporting method(s). Refer to Section 9.4 for detailed reporting instructions.
Narrative content for the ResearchStudy.
Representation of amendments to a study protocol.
The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
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 managable, 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).
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.
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](http://build.fhir.org/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Canonical identifier for this study resource
Canonical identifier for this study resource, represented as a globally unique URI.
Identifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Organization's Unique Protocol ID; Secondary IDs
No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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 managable, 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.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found [here](http://hl7.org/fhir/R5/identifier-registry.html).
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
The business version for the study record
The business version for the study record.
Name for this study (computer friendly).
The human readable name of the research study.
The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches.
No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
All FHIR elements must have a @value or children or both
Extensions that cannot be ignored even if unrecognized
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 managable, 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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
The value set used here is defined by CDISC/DDF
The set of steps expected to be performed as part of the execution of the study.
Interventions; Arm/Intervention Cross-Reference
A larger research study of which this particular study is a component or step.
Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Display of the bibliographic citation of this ResearchStudy.
Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist.
documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
The type of relationship to the related artifact.
Set to a value of predecessor to indicate the target is the previous version of the protocol
The artifact that is related to this ResearchStudy
The artifact that is related to this ResearchStudy Resource.
The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.
The publication state of the resource (not of the study).
This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Codes that convey the current publication status of the research study resource.
treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
The type of study based upon the intent of the study activities. A classification of the intent of the study.
The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
M11 has specified its own preferred terms rather than NCI terms and these should be provided in the display element of the coding.
Classifications of the study design characteristics
Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
This is a set of terms for study design characteristics.
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Expect MedicinalProductDefinition.name.type.code to be one of C71898 Proprietary name or C97054 Non-proprietary name
Some example codes of research study focus
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.
Identification of the condition or diagnosis.
Key terms to aid in searching for or filtering the study.
DocumentVersion.keywordCode; DocumentVersion.keywordText
A country, state or other area where the study is taking place rather than its precise geographic location or address.
Countries and regions within which this artifact is targeted for use.
A detailed and human-readable narrative of the study. E.g., study abstract.
Identifies the start date and the expected (or actual, depending on status) end date for the study.
Study Start Date (start); Study Completion Date (end)
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
Facility where study activities are conducted
A facility in which study activities are conducted.
Comments made about the study by the performer, subject or other participants.
.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.
Sponsors, collaborators, and other parties
Sponsors, collaborators, and other parties.
For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.
sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
NCI has study roles defined - M11 only requires a limited set of these
Identifies the start date and the end date of the associated party in the role.
The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.
nih | fda | government | nonprofit | academic | industry
A categorization other than role for the associated party.
A characterization or type of the entity.
Individual or organization associated with study (use practitionerRole to specify their organisation)
Individual or organization associated with study (use practitionerRole to specify their organisation).
Suggestions of a better attribute name are appreciated
Status of study with time for that status
Status of study with time for that status.
Label for status or state (e.g. recruitment status)
Label for status or state (e.g. recruitment status).
An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.
accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
A description and/or code explaining the premature termination of the study.
Codes for why the study ended prematurely.
Target or actual group of participants enrolled in study
Target or actual group of participants enrolled in study.
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
Estimated total number of participants to be enrolled
Estimated total number of participants to be enrolled.
Actual total number of participants enrolled in study
Actual total number of participants enrolled in study.
Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
Group of participants who were enrolled in study
Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'.
Defined path through the study for a subject
Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.
In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.
Estimated total number of participants to be enrolled in the comparison group
Estimated total number of participants to be enrolled in the comparison group.
Actual total number of participants enrolled in the comparison group
Actual total number of participants enrolled in the comparison group.
Inclusion and exclusion criteria for the comparison group
Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
Group of participants who were enrolled in the comparison group
Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'.
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.
Unique, human-readable label for this objective of the study.
No BRIDG mapping (BRIDG has a description, but not a name)
Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).
An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP
To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id
Statistical measure for treatment effect estimate
Statistical measure for treatment effect estimate.
The type of a statistic, e.g. relative risk or mean.
The group that is affected by this event handling
The group that is affected by this event handling.
Link to results generated during the study
Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.
Protocols may have multiple business identifers from a given system - only with a type can they be distinguished.