Researchstudy.shex

ShEx statement for researchstudy

PREFIX fhir: <http://hl7.org/fhir/> 
PREFIX fhirvs: <http://hl7.org/fhir/ValueSet/>
PREFIX xsd: <http://www.w3.org/2001/XMLSchema#> 
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> 

# ShEx Version 2.2
IMPORT <Uri.shex>
IMPORT <Code.shex>
IMPORT <Group.shex>
IMPORT <Period.shex>
IMPORT <String.shex>
IMPORT <Boolean.shex>
IMPORT <DateTime.shex>
IMPORT <Evidence.shex>
IMPORT <Location.shex>
IMPORT <Markdown.shex>
IMPORT <Resource.shex>
IMPORT <Canonical.shex>
IMPORT <Reference.shex>
IMPORT <Annotation.shex>
IMPORT <Attachment.shex>
IMPORT <Identifier.shex>
IMPORT <Composition.shex>
IMPORT <UnsignedInt.shex>
IMPORT <Organization.shex>
IMPORT <Practitioner.shex>
IMPORT <DomainResource.shex>
IMPORT <PlanDefinition.shex>
IMPORT <BackboneElement.shex>
IMPORT <CodeableConcept.shex>
IMPORT <DiagnosticReport.shex>
IMPORT <EvidenceVariable.shex>
IMPORT <PractitionerRole.shex>
IMPORT <CodeableReference.shex>
IMPORT <DocumentReference.shex>

start=@<ResearchStudy> AND {fhir:nodeRole [fhir:treeRoot]}

# Investigation to increase healthcare-related patient-independent knowledge
<ResearchStudy> EXTENDS @<DomainResource> CLOSED {   
    a [fhir:ResearchStudy]?;fhir:nodeRole [fhir:treeRoot]?;

    fhir:url @<Uri>?;                       # Canonical identifier for this 
                                            # study resource 
    fhir:identifier @<OneOrMore_Identifier>?;  # Business Identifier for study
    fhir:version @<String>?;                # The business version for the study 
                                            # record 
    fhir:name @<String>?;                   # Name for this study (computer 
                                            # friendly) 
    fhir:title @<String>?;                  # Human readable name of the study
    fhir:label @<OneOrMore_ResearchStudy.label>?;  # Additional names for the study
    fhir:protocol @<OneOrMore_Reference_PlanDefinition>?;  # Steps followed in executing study
    fhir:partOf @<OneOrMore_Reference_ResearchStudy>?;  # Part of larger study
    fhir:citeAs @<Markdown>?;               # How to cite this ResearchStudy
    fhir:relatesTo @<OneOrMore_ResearchStudy.relatesTo>?;  # Relationships to other Resources
    fhir:date @<DateTime>?;                 # Date the resource last changed
    fhir:status @<Code> AND
    	{fhir:v @fhirvs:publication-status};  # draft | active | retired | unknown
    fhir:purposeType @<OneOrMore_CodeableConcept>?;  # treatment | prevention | 
                                            # diagnostic | supportive-care | 
                                            # screening | 
                                            # health-services-research | 
                                            # basic-science | device-feasibility 
    fhir:phase @<CodeableConcept>?;         # Classifier used for clinical trials
    fhir:studyDesign @<OneOrMore_CodeableConcept>?;  # Classifications of the study 
                                            # design characteristics 
    fhir:focus @<OneOrMore_CodeableReference>?;  # Drugs, devices, etc. under study
    fhir:condition @<OneOrMore_CodeableConcept>?;  # Condition being studied
    fhir:keyword @<OneOrMore_CodeableConcept>?;  # Used to search for the study
    fhir:region @<OneOrMore_CodeableConcept>?;  # Geographic area for the study
    fhir:descriptionSummary @<Markdown>?;   # Brief text explaining the study
    fhir:description @<Markdown>?;          # Detailed narrative of the study
    fhir:period @<Period>?;                 # When the study began and ended
    fhir:site @<OneOrMore_Reference_Location_OR_Organization_OR_ResearchStudy>?;  # Facility where study activities 
                                            # are conducted 
    fhir:note @<OneOrMore_Annotation>?;     # Comments made about the study
    fhir:classifier @<OneOrMore_CodeableConcept>?;  # Classification for the study
    fhir:associatedParty @<OneOrMore_ResearchStudy.associatedParty>?;  # Sponsors, collaborators, and other 
                                            # parties 
    fhir:progressStatus @<OneOrMore_ResearchStudy.progressStatus>?;  # Dates for status changes for the 
                                            # conduct of the study, or study 
                                            # registry and administrative 
                                            # actions 
    fhir:whyStopped @<CodeableConcept>?;    # accrual-goal-met | 
                                            # closed-due-to-toxicity | 
                                            # closed-due-to-lack-of-study-prog-
                                            # ress | 
                                            # temporarily-closed-per-study-des-
                                            # ign 
    fhir:recruitment @<ResearchStudy.recruitment>?;  # Target or actual group of 
                                            # participants enrolled in study 
    fhir:comparisonGroup @<OneOrMore_ResearchStudy.comparisonGroup>?;  # Defined path through the study for 
                                            # a subject 
    fhir:objective @<OneOrMore_ResearchStudy.objective>?;  # A goal for the study
    fhir:result @<OneOrMore_Reference_Composition_OR_DiagnosticReport_OR_DocumentReference_OR_Evidence>?;  # Link to results generated during 
                                            # the study 
}  

# Additional names for the study
<ResearchStudy.label> EXTENDS @<BackboneElement> CLOSED {   
    fhir:type @<CodeableConcept>?;          # primary | official | scientific | 
                                            # plain-language | subtitle | 
                                            # short-title | acronym | 
                                            # earlier-title | language | 
                                            # auto-translated | human-use | 
                                            # machine-use | duplicate-uid 
    fhir:value @<String>?;                  # The name
    fhir:language @<Code> AND
    	{fhir:v @fhirvs:all-languages}?;  # Used to express the specific 
                                            # language 
}  

# Relationships to other Resources
<ResearchStudy.relatesTo> EXTENDS @<BackboneElement> CLOSED {   
    fhir:type @<CodeableConcept>;           # documentation | justification | 
                                            # citation | 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 | documents | 
                                            # specification-of | created-with | 
                                            # cite-as | reprint | reprint-of | 
                                            # summarizes 
    fhir:target @<Uri>  OR 
    			@<Attachment>  OR 
    			(@<Canonical>  AND {fhir:l @<Resource> })  OR 
    			(@<Reference>  AND {fhir:l @<Resource> })  OR 
    			@<Markdown>  ;  # The artifact that is related to 
                                            # this ResearchStudy 
}  

# Sponsors, collaborators, and other parties
<ResearchStudy.associatedParty> EXTENDS @<BackboneElement> CLOSED {   
    fhir:name @<String>?;                   # Name of associated party
    fhir:role @<CodeableConcept>;           # sponsor | lead-sponsor | 
                                            # sponsor-investigator | 
                                            # primary-investigator | 
                                            # collaborator | funding-source | 
                                            # general-contact | 
                                            # recruitment-contact | 
                                            # sub-investigator | study-chair | 
                                            # irb | data-monitoring 
    fhir:period @<OneOrMore_Period>?;       # When active in the role
    fhir:classifier @<OneOrMore_CodeableConcept>?;  # nih | fda | government | nonprofit 
                                            # | academic | industry 
    fhir:party @<Reference> AND {fhir:l 
    			@<Organization> OR 
    			@<Practitioner> OR 
    			@<PractitionerRole> ? }?;  # Individual or organization 
                                            # associated with study (use 
                                            # practitionerRole to specify their 
                                            # organisation) 
}  

# Dates for status changes for the conduct of the study, or study registry and administrative actions
<ResearchStudy.progressStatus> EXTENDS @<BackboneElement> CLOSED {   
    fhir:state @<CodeableConcept>;          # Label for status or state (e.g. 
                                            # recruitment status) 
    fhir:actual @<Boolean>?;                # Actual if true else anticipated
    fhir:period @<Period>?;                 # Date range
}  

# Target or actual group of participants enrolled in study
<ResearchStudy.recruitment> EXTENDS @<BackboneElement> CLOSED {   
    fhir:targetNumber @<UnsignedInt>?;      # Estimated total number of 
                                            # participants to be enrolled 
    fhir:actualNumber @<UnsignedInt>?;      # Actual total number of 
                                            # participants enrolled in study 
    fhir:eligibility @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Inclusion and exclusion criteria
    fhir:actualGroup @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Group of participants who were 
                                            # enrolled in study 
    fhir:description @<Markdown>?;          # Description of the recruitment
}  

# Defined path through the study for a subject
<ResearchStudy.comparisonGroup> EXTENDS @<BackboneElement> CLOSED {   
    fhir:targetNumber @<UnsignedInt>?;      # Estimated total number of 
                                            # participants to be enrolled in the 
                                            # comparison group 
    fhir:actualNumber @<UnsignedInt>?;      # Actual total number of 
                                            # participants enrolled in the 
                                            # comparison group 
    fhir:eligibility @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Inclusion and exclusion criteria 
                                            # for the comparison group 
    fhir:observedGroup @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Group of participants who were 
                                            # enrolled in the comparison group 
    fhir:name @<String>?;                   # A simple label for the comparison 
                                            # Group 
    fhir:description @<Markdown>?;          # Description of the comparison Group
}  

# A goal for the study
<ResearchStudy.objective> EXTENDS @<BackboneElement> CLOSED {   
    fhir:name @<String>?;                   # Label for the objective
    fhir:type @<CodeableConcept>?;          # primary | secondary | exploratory
    fhir:description @<Markdown>?;          # Description of the objective
    fhir:outcomeMeasure @<OneOrMore_ResearchStudy.objective.outcomeMeasure>?;  # A variable measured during the 
                                            # study 
}  

# A variable measured during the study
<ResearchStudy.objective.outcomeMeasure> EXTENDS @<BackboneElement> CLOSED {   
    fhir:name @<String>?;                   # Label for the outcome measure
    fhir:type @<CodeableConcept>?;          # primary | secondary | exploratory
    fhir:description @<Markdown>?;          # Description of the outcome measure
    fhir:endpoint @<Reference> AND {fhir:l 
    			@<EvidenceVariable> ? };  # Definition of the outcome measure
    fhir:population @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Population for this estimand
    fhir:intervention @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Comparison group of interest
    fhir:comparator @<Reference> AND {fhir:l 
    			@<Group> ? }?;  # Comparison group for comparison
    fhir:summaryMeasure @<CodeableConcept>?;  # Statistical measure for treatment 
                                            # effect estimate 
    fhir:endpointAnalysisPlan @<Reference> AND {fhir:l 
    			@<Evidence> ? }?;  # Statistical analysis plan for a 
                                            # single endpoint 
    fhir:eventHandling @<OneOrMore_ResearchStudy.objective.outcomeMeasure.eventHandling>?;  # Handling of intercurrent event
}  

# Handling of intercurrent event
<ResearchStudy.objective.outcomeMeasure.eventHandling> EXTENDS @<BackboneElement> CLOSED {   
    fhir:event @<CodeableConcept>?;         # The event
    fhir:group @<CodeableConcept>?;         # The group that is affected by this 
                                            # event handling 
    fhir:handling @<CodeableConcept>?;      # How the data is handled
    fhir:description @<Markdown>?;          # Text summary of event handling
}  

#---------------------- Cardinality Types (OneOrMore) -------------------
<OneOrMore_Identifier> CLOSED {
    rdf:first @<Identifier>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Identifier> 
}
<OneOrMore_ResearchStudy.label> CLOSED {
    rdf:first @<ResearchStudy.label>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.label> 
}
<OneOrMore_Reference_PlanDefinition> CLOSED {
    rdf:first @<Reference> AND {fhir:l 
			@<PlanDefinition> } ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Reference_PlanDefinition> 
}
<OneOrMore_Reference_ResearchStudy> CLOSED {
    rdf:first @<Reference> AND {fhir:l 
			@<ResearchStudy> } ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Reference_ResearchStudy> 
}
<OneOrMore_ResearchStudy.relatesTo> CLOSED {
    rdf:first @<ResearchStudy.relatesTo>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.relatesTo> 
}
<OneOrMore_CodeableConcept> CLOSED {
    rdf:first @<CodeableConcept>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_CodeableConcept> 
}
<OneOrMore_CodeableReference> CLOSED {
    rdf:first @<CodeableReference>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_CodeableReference> 
}
<OneOrMore_Reference_Location_OR_Organization_OR_ResearchStudy> CLOSED {
    rdf:first @<Reference> AND {fhir:l 
			@<Location> OR 
			@<Organization> OR 
			@<ResearchStudy> } ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Reference_Location_OR_Organization_OR_ResearchStudy> 
}
<OneOrMore_Annotation> CLOSED {
    rdf:first @<Annotation>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Annotation> 
}
<OneOrMore_ResearchStudy.associatedParty> CLOSED {
    rdf:first @<ResearchStudy.associatedParty>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.associatedParty> 
}
<OneOrMore_ResearchStudy.progressStatus> CLOSED {
    rdf:first @<ResearchStudy.progressStatus>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.progressStatus> 
}
<OneOrMore_ResearchStudy.comparisonGroup> CLOSED {
    rdf:first @<ResearchStudy.comparisonGroup>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.comparisonGroup> 
}
<OneOrMore_ResearchStudy.objective> CLOSED {
    rdf:first @<ResearchStudy.objective>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.objective> 
}
<OneOrMore_Reference_Composition_OR_DiagnosticReport_OR_DocumentReference_OR_Evidence> CLOSED {
    rdf:first @<Reference> AND {fhir:l 
			@<Composition> OR 
			@<DiagnosticReport> OR 
			@<DocumentReference> OR 
			@<Evidence> } ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Reference_Composition_OR_DiagnosticReport_OR_DocumentReference_OR_Evidence> 
}
<OneOrMore_Period> CLOSED {
    rdf:first @<Period>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_Period> 
}
<OneOrMore_ResearchStudy.objective.outcomeMeasure> CLOSED {
    rdf:first @<ResearchStudy.objective.outcomeMeasure>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.objective.outcomeMeasure> 
}
<OneOrMore_ResearchStudy.objective.outcomeMeasure.eventHandling> CLOSED {
    rdf:first @<ResearchStudy.objective.outcomeMeasure.eventHandling>  ;
    rdf:rest [rdf:nil] OR @<OneOrMore_ResearchStudy.objective.outcomeMeasure.eventHandling> 
}

#---------------------- Value Sets ------------------------

# This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47)
fhirvs:all-languages ["aa" "ab" "ace" "ach" "ada" "ady" "ae" "af" "afa" "afh" "ain" "ak" "akk" "ale" "alg" "alt" "am" "an" "ang" "anp" "apa" "ar" "arc" "arn" "arp" "art" "arw" "as" "ast" "ath" "aus" "av" "awa" "ay" "az" "ba" "bad" "bai" "bal" "ban" "bas" "bat" "be" "bej" "bem" "ber" "bg" "bho" "bi" "bik" "bin" "bla" "bm" "bn" "bnt" "bo" "br" "bra" "bs" "btk" "bua" "bug" "byn" "ca" "cad" "cai" "car" "cau" "ce" "ceb" "cel" "ch" "chb" "chg" "chk" "chm" "chn" "cho" "chp" "chr" "chy" "cmc" "cnr" "co" "cop" "cpe" "cpf" "cpp" "cr" "crh" "crp" "cs" "csb" "cu" "cus" "cv" "cy" "da" "dak" "dar" "day" "de" "del" "den" "dgr" "din" "doi" "dra" "dsb" "dua" "dum" "dv" "dyu" "dz" "ee" "efi" "egy" "eka" "el" "elx" "en" "enm" "eo" "es" "et" "eu" "ewo" "fa" "fan" "fat" "ff" "fi" "fil" "fiu" "fj" "fo" "fon" "fr" "frm" "fro" "frr" "frs" "fur" "fy" "ga" "gaa" "gay" "gba" "gd" "gem" "gez" "gil" "gl" "gmh" "gn" "goh" "gon" "gor" "got" "grb" "grc" "gsw" "gu" "gv" "gwi" "ha" "hai" "haw" "he" "hi" "hil" "him" "hit" "hmn" "ho" "hr" "hsb" "ht" "hu" "hup" "hy" "hz" "ia" "iba" "id" "ie" "ig" "ii" "ijo" "ik" "ilo" "inc" "ine" "inh" "io" "ira" "iro" "is" "it" "iu" "ja" "jbo" "jpr" "jrb" "jv" "ka" "kaa" "kab" "kac" "kam" "kar" "kaw" "kbd" "kg" "kha" "khi" "kho" "ki" "kj" "kk" "kl" "km" "kmb" "kn" "ko" "kok" "kos" "kpe" "kr" "krc" "krl" "kro" "kru" "ks" "ku" "kum" "kut" "kv" "kw" "ky" "la" "lad" "lah" "lam" "lb" "lez" "lg" "li" "ln" "lo" "lol" "loz" "lt" "lu" "lua" "lui" "lun" "luo" "lus" "lv" "mad" "mag" "mai" "mak" "man" "map" "mas" "mdf" "mdr" "men" "mg" "mga" "mh" "mi" "mic" "min" "mis" "mk" "mkh" "ml" "mn" "mnc" "mni" "mno" "moh" "mos" "mr" "ms" "mt" "mul" "mun" "mus" "mwl" "mwr" "my" "myn" "myv" "na" "nah" "nai" "nap" "nb" "nd" "nds" "ne" "new" "ng" "nia" "nic" "niu" "nl" "nn" "no" "nog" "non" "nqo" "nr" "nso" "nub" "nv" "nwc" "ny" "nym" "nyn" "nyo" "nzi" "oc" "oj" "om" "or" "os" "osa" "ota" "oto" "pa" "paa" "pag" "pal" "pam" "pap" "pau" "peo" "phi" "phn" "pi" "pl" "pon" "pra" "pro" "ps" "pt" "qu" "raj" "rap" "rar" "rm" "rn" "ro" "roa" "rom" "ru" "rup" "rw" "sa" "sad" "sah" "sai" "sal" "sam" "sas" "sat" "sc" "scn" "sco" "sd" "se" "sel" "sem" "sg" "sga" "sgn" "shn" "si" "sid" "sio" "sit" "sk" "sl" "sla" "sm" "sma" "smi" "smj" "smn" "sms" "sn" "snk" "so" "sog" "son" "sq" "sr" "srn" "srr" "ss" "ssa" "st" "su" "suk" "sus" "sux" "sv" "sw" "syc" "syr" "ta" "tai" "te" "tem" "ter" "tet" "tg" "th" "ti" "tig" "tiv" "tk" "tkl" "tl" "tlh" "tli" "tmh" "tn" "to" "tog" "tpi" "tr" "ts" "tsi" "tt" "tum" "tup" "tut" "tvl" "tw" "ty" "tyv" "udm" "ug" "uga" "uk" "umb" "und" "ur" "uz" "vai" "ve" "vi" "vo" "vot" "wa" "wak" "wal" "war" "was" "wen" "wo" "xal" "xh" "yao" "yap" "yi" "yo" "ypk" "za" "zap" "zbl" "zen" "zgh" "zh" "znd" "zu" "zun" "zxx" "zza"]

# The lifecycle status of an artifact.
fhirvs:publication-status ["draft" "active" "retired" "unknown"]