SPL V2b Subgroup, Feb 2005
53
1 SPL V2b Subgroup, Feb 2005 Brief Overview of the Current Draft SPL V2b Specification: Clinical Product Information Module and Related Features
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Brief Overview of the Current Draft SPL V2b Specification: Clinical Product Information Module and Related Features. SPL V2b Subgroup, Feb 2005. - PowerPoint PPT Presentation
Transcript of SPL V2b Subgroup, Feb 2005
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SPL V2b Subgroup, Feb 2005
Brief Overview of the Current Draft SPL V2b Specification:
Clinical Product Information Module and Related Features
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SPL V2b Subgroup, Feb 2005
Much of the following is significantly simplified and designed to create a good visual representation of principles rather than a technically correct representation
of the details of the SPL standard.
3
What this is about …
SPL V2b Subgroup, Feb 2005
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Contraindications
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• Asgf ajksdg fkjag adgf jakgf jkasdgf ajgf jagf ajgf ajk kajgf ajgf kajfhjg ajs asgf ajkgf jasgh jkghfkjasghf jkaghf agsd asjgh ashf asf aksgf jas asgf jkasgd fjkasgh ajsg jsdf jksg jasghf
• hf ajsdg fjasg jksgsg j- gh dkasfjh gskah gkasdfh fkla- mhcg ag ,amcv ,ZXCV axkjcvax h ah akhjklahakh ka
Ijzhgfgfjagh jhgfjk gf jasghl asjgf jla as[dtuqs][tu[qiort t fg jkfdg kdfajagh ak;hg adfhg afkdgh kladfg ngf a,ga jhgas lahg asglas lajkhg asgh jkgfoiaghfialh gkqwjsgh kjsdfh gjklsdfhg jkdfhgkldfha lgjkfh gsdjkfh gjkdhasfgkjsdfgjkldfhg jdfgh ljkdfgh kldfjsgh ksdfljh gklsdjfhg kdfjsh ghdsfkljgh klsdfjgh ksdfjgh kldsfh gksdfjghsdkfjgh kdfgh kdsfhgkjdfh lsdkfjh gkdjsfg sdfh gjksldgsjkldfhgksdjlf g
Asf asjkdfjksfjasjdgfjgasdjklf galgfjkasdfgaskjdghasdhgfdasjgf jasdgf hjag jaj ajsd jgf jasdfgdjksag jgfaj
HRL Human Readable Labeling
CRL Computer Readable Labeling
How to get from HRL to CRL ?
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SPL V2b Subgroup, Feb 2005
Before we answer this question …
… let’s have a look at how computers (clinical decision support systems) use CRL.
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SPL V2b Subgroup, Feb 2005
How Clinical Decision Support Systems use Computer-Readable Labeling
Use of C-Labeling by Computers
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Use of C-Labeling by Computers
SPL V2b Subgroup, Feb 2005
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CRL (e.g. Contraindications)
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E-Patient Record (e.g. Diagnoses)
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SPL V2b Subgroup, Feb 2005
754-7239-54 35412358745
344---239-54 37636745
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344---239-54 3541256666
CRL (e.g. Contraindications)
333-5656--1 344444--744
155---239-34 2228936745
155---239-66 7559931119
155---239-47 3541256666
E-Patient Record (e.g. Diagnoses)
Use of C-Labeling by Computers
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SPL V2b Subgroup, Feb 2005
754-7239-54 35412358745
344---239-54 37636745
995-7239-62 15145358745
344---239-54 3541231119
344---239-54 3541256666
CRL (e.g. Contraindications)
E-Patient Record (e.g. Diagnoses)
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155---239-34 2228936745
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Match
Use of C-Labeling by Computers
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SPL V2b Subgroup, Feb 2005
754-7239-54 35412358745
344---239-54 37636745
995-7239-62 15145358745
344---239-54 3541231119
344---239-54 3541256666
CRL (e.g. Contraindications)
E-Patient Record (e.g. Diagnoses)
333-5656--1 344444--744
155---239-34 2228936745
155---239-66 7559931119
155---239-47 3541256666
Match
Use of C-Labeling by Computers
“Doctor, I found a contraindication.
DO NOT PRESCRIBE THIS
DRUG !”
“Doctor, I found a contraindication.
DO NOT PRESCRIBE THIS
DRUG !”
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SPL V2b Subgroup, Feb 2005
754-7239-54 35412358745
344---239-54 37636745
995-7239-62 15145358745
344---239-54 3541231119
344---239-54 3541256666
CRL (e.g. Contraindications)
333-5656--1 344444--744
155---239-34 2228936745
155---239-66 7559931119
155---239-47 3541256666
E-Patient Record (e.g. Diagnoses)
Need totalk thesame language(code)
Use of C-Labeling by Computers
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SPL V2b Subgroup, Feb 2005
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CRL (e.g. Contraindications)
Structuring and coding should be limited to what is necessary for a computer to generate meaningful alerts.
It’s not l’art pour l’art
Use of C-Labeling by Computers
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SPL V2b Subgroup, Feb 2005
Now back to our original question:
How do we get from human readable labeling to computer readable labeling?
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SPL V2b Subgroup, Feb 2005
Now back to our original question:
How do we get from human readable labeling to computer readable labeling without losing human readability?
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SPL V2b Subgroup, Feb 2005
The Principles of Making Labeling Computer Readable
General Principles
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General Principles
SPL V2b Subgroup, Feb 2005
It’s not that difficult. XML technology helps us do the trick:
The electronic document contains both the human readable text and the computer readable structured content with codes.
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SPL V2b Subgroup, Feb 2005
It’s not that difficult. XML technology helps us do the trick:
The electronic document contains both the human readable text and the computer readable structured content with codes.
Humans will see/print a neatly formatted text.
Computers can find the codes and interpret them correctly.
General Principles
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SPL V2b Subgroup, Feb 2005
XML technology and encoding allows us to “translate” the meaning and the logical structure of labeling content into a corresponding structured set of codes. This is achieved by
• flagging (“tagging”) individual concepts (such a dizziness, hypotension, 40 mg)
• assigning an information type to these concepts (e.g.: Is hypertension the indication, a contraindication, or an ADR?)
• defining the “formal” and “logical” relationship between elements (Is common the frequency of rash or nausea? Is dizziness the cause of something or the consequence?),
• and encoding the medical concepts (e.g. dizziness becomes 1234567890)
General Principles
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SPL V2b Subgroup, Feb 2005
The SPL V2b Clinical Product Information Module provides the rules and tools for
• tagging and assigning an information type to clinical concepts in a product label,
• defining the formal and logical relationship between tagged elements, and
• capturing the codes for the medical concepts.
It also allows us to define “wording elements” for the Highlights section, “connected to the corresponding full text paragraphs” and auto-displayed in the Highlights section.
General Principles
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SPL V2b Subgroup, Feb 2005
The SPL V2b Clinical Product Information Module provides the rules and tools for
• tagging and assigning an information type to clinical concepts in a product label,
• defining the formal and logical relationship between tagged elements, and
• capturing the codes for the medical concepts.
It also allows us to define “wording elements” for the Highlights section, “connected to the corresponding full text paragraphs” and auto-displayed in the Highlights section.
General Principles
We are asked to review and helpimprove these rules and tools,
as necessary.
We are asked to review and helpimprove these rules and tools,
as necessary.
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SPL V2b Subgroup, Feb 2005
The crux of the module is the excerpt, which “abstracts” or “elevates” content from the narrative and provides metadata about that content:
• Electronically enables “Highlights” from the US Proposed New Labeling Rule – Federal Register, December 22,
2000; CFR 65(247):81082-81131
• Provides a machine-readable “flag” to product use content found in the narrative
• Code systems ensure consistency in excerpt content and interoperability with other clinical decision-support
systems (CDSS)
• Defining this information (coding it unambiguously) in a consistent and machine-readable way enables controlled information management in CDSS
Clinical Product Information Module
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SPL V2b Subgroup, Feb 2005
Macro-Anatomyof the Clinical Product Information Module
Macro-Anatomy
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1 INDICATIONS AND USAGEPRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,
Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis.
1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus.
1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]).*MDRSP, Multi-drug resistant Streptococcus pneumoniae includes ….
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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Macro-Anatomy
SPL V2b Subgroup, Feb 2005
Computer ReadableLabeling
H Human Readable
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1 INDICATIONS AND USAGEPRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,
Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis.
1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus.
1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]).*MDRSP, Multi-drug resistant Streptococcus pneumoniae includes ….
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
754-7239-54 2424243111 111-31111 1223344332
1211-76664 7856983756
1211-76664 7452314577
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1211-76664 7555553756
SPL V2b Subgroup, Feb 2005
Computer ReadableLabeling
H Human Readable
This is not how itlooks in reality. It’s just a
visualization of the principle.
This is not how itlooks in reality. It’s just a
visualization of the principle.
Macro-Anatomy
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1 INDICATIONS AND USAGEPRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,
Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis.
1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus.
1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]).*MDRSP, Multi-drug resistant Streptococcus pneumoniae includes ….
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
SPL V2b Subgroup, Feb 2005
H Human Readable
SPL V2b Subgroup, Feb 2005
754-7239-54 2424243111 111-31111 1223344332
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1211-76664 7452314577
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Computer ReadableLabeling
Corresponding wording for Highlights section: “Acute bacterial exacerbation of chronic bursitis …”
Corresponding wording for Highlights section: “Acute bacterial exacerbation of chronic bursitis …”
Macro-Anatomy
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1 INDICATIONS AND USAGEPRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,
Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis.
1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus.
1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]).*MDRSP, Multi-drug resistant Streptococcus pneumoniae includes ….
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
SPL V2b Subgroup, Feb 2005
H Human Readable
SPL V2b Subgroup, Feb 2005
754-7239-54 2424243111 111-31111 1223344332
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Computer ReadableLabeling
Corresponding wording for Highlights section: “Acute bacterial exacerbation of chronic bursitis …”
Corresponding wording for Highlights section: “Acute bacterial exacerbation of chronic bursitis …”
• CRL and Highlights wording are “parallel elements”.
• CRL can cover more content thanHighlights wording.
• CRL can exist without Highlightswording.
• CRL and Highlights wording are “parallel elements”.
• CRL can cover more content thanHighlights wording.
• CRL can exist without Highlightswording.
Macro-Anatomy
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SPL V2b Subgroup, Feb 2005
Highlights element
CRL
“Excerpt”
Macro-Anatomy
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SPL V2b Subgroup, Feb 2005
Highlights element
CRL
“Excerpt”
Macro-Anatomy
Not every subsection
needs to have an Excerpt.
Not every subsection
needs to have an Excerpt.
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SPL V2b Subgroup, Feb 2005
Highlights element
CRL
“Excerpt”
Macro-Anatomy
Not every Excerpt needs
to have Highlights wording.
Not every Excerpt needs
to have Highlights wording.
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SPL V2b Subgroup, Feb 2005
They are invisible ina regular browserview or printout …
In SPL, excerpts can sit underneath each
subsection.
Macro-Anatomy
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Highlights
SPL V2b Subgroup, Feb 2005
… except for Highlights wording, which is
auto-displayed in the Highlights section
Macro-Anatomy
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SPL V2b Subgroup, Feb 2005
Let us now look at the rules and tools forassigning an information type to clinical concepts and maintaining the “logical relationship” between them.
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SPL V2b Subgroup, Feb 2005
Assigning an Information Type to Individual Clinical Concepts and Maintaining their
Relationship
Capturing Information Types and Relationships
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Capturing Information Types and Relationships
SPL V2b Subgroup, Feb 2005
For humans, we use three mechanisms to tell physicians what to do and/or how to interpret information.
• Calling certain conditions “names”, such as indication, contraindication, non-indication, ADR, interaction.
• Providing explicit advice, e.g. “do monitor patients with XYZ for …”, “… carefully weigh the benefits and risks in patients with …”
• Implying actions (not being explicit). It is usually not necessary to tell a physician to carefully weigh the benefits and risks in the presence of serious risks. They know to do that anyway.
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SPL V2b Subgroup, Feb 2005
For humans, we use three mechanisms to tell physicians what to do and/or how to interpret information.
• Calling certain conditions “names”, such as indication, contraindication, non-indication, ADR, interaction.
• Providing explicit advice, e.g. “do monitor patients with XYZ for …”, “… carefully weigh the benefits and risks in patients with …”
• Implying actions (non being explicit). It is usually not necessary to tell a physician to carefully weigh the benefits and risks in the presence of serious risks. They do that anyway.
Capturing Information Types and Relationships
Computer readable labeling has totell computers how to “interpret”labeling content so that they can act.
Possible actions include:• Preventing a prescription unless
overruled, or at least• Displaying information to physicians
so that these can act.
Computer readable labeling has totell computers how to “interpret”labeling content so that they can act.
Possible actions include:• Preventing a prescription unless
overruled, or at least• Displaying information to physicians
so that these can act.
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SPL V2b Subgroup, Feb 2005
As an important means of telling computers how to interpret labeling content, the SPL spec defines “classes” of information.
These classes (sort of) tell a computer how to interpret content and, possibly, act.
Clinical information needs to be put in those classes to become computer interpretable and actable.
Capturing Information Types and Relationships
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SPL V2b Subgroup, Feb 2005
As an important means of telling computers how to interpret labeling content, the SPL spec defines “classes” of information.
These classes (sort of) tell a computer how to interpret content and, possibly, act.
Clinical information needs to be put in those classes to become computer interpretable and actable.
Capturing Information Types and Relationships
STRANGENAMES
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SPL V2b Subgroup, Feb 2005
Here are some examples of classes:
IndicationObservationCriterion Reason for substance administration
ClinicalSituationCriterionLimits indication to special population/situation(e.g. age group) – is a precondition
TreatmentClassDescribes the intent of treatment, e.g. for ß-blocker“antihypertensive” or “antiarrhytmic”
CLASS
MonitoringObservationSteps Tests to be performed, and their frequency
Issue Adverse reaction, interaction, …
Capturing Information Types and Relationships
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SPL V2b Subgroup, Feb 2005
It is very important that SPL has all the classes necessary to capture important clinical information.
Capturing Information Types and Relationships
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SPL V2b Subgroup, Feb 2005
Let us now gofrom 35,000 ft
down to 10,000 ft.
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SPL V2b Subgroup, Feb 2005
SPL r2 Overview (10000 ft)
0..* sectionReplaced
typeCode*: <= RPLCcontextConductionInd: BL "false"
replacementOf
0..1 highlight
typeCode *: <= XCRPT
excerpt
CharacteristicclassCode *: <= OBSmoodCode *: <= EVNcode*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]value*: ANY [0..1]
SPL_RMIM_LEVEL_2(PORR_RM050024)
This shared RMIM is used forproduct labeling, such as the humanprescription drug labeling
DocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]code *: CE CWE [1..1] <=DocumentTypetitle: ST [0..1]effectiveTime *: TS [1..1]availabilityTime: TS [0..1] (Releasedate)confidentialityCode: CE CWE [0..1] <= ConfidentialityByAccessKindlanguageCode: CS CNE [0..1] <=HumanLanguagesetId: II [0..1]versionNumber: INT [0..1]
ObservationMediaclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]value *: ED [1..1]
NonXMLBodyclassCode *: <= DOCBODYmoodCode *: <= EVNtext *: ED [1..1]
StructuredBodyclassCode *: <= DOCBODYmoodCode *: <= EVN
ObservationclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]confidentialityCode*: CE CWE [0..1] <= ConfidentialityByAccessKindvalue*: ANY [0..1]
0..1 person
0..1 representedOrganization
AssignedEntityclassCode *: <= ASSIGNEDid*: II [0..1]addr: AD [0..1]telecom: BAG<TEL> [0..*]
PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname*: BAG<PN> [0..*]
OrganizationclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [0..1]name*: ON [0..1]telecom: TEL [0..1]addr: AD [0..1]
0..* assignedEntity
verifiertypeCode*: <= VRF (reviewer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
RelatedDocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]setId: II [0..1]versionNumber: INT [0..1]
0..* relatedDocument
typeCode*: <= x_ActRelationshipDocumentcontextConductionInd: BL "false"
relatedDocument
0..* assignedEntity
legalAuthenticatortypeCode*: <= LA (legal authenticator at manufacturer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
0..* assignedEntity
authortypeCode*: <= AUT (author at manufacturer)contextControlCode: CS CNE [0..1] <= "OP"time *: TS [1..1]
SectionComponent
component
0..* sectionComponent
typeCode*: <= COMPcontextConductionInd: BL [0..1] "true"
1..1 documentBodyChoice
componenttypeCode*: <= COMPcontextConductionInd: BL "true"
DocumentBodyChoice
SectionReplacedclassCode *: <= DOCSECTmoodCode *: <= EVNid*: II [1..1]
GenericMedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode: CE CWE <= DrugEntityname*: TN [1..1] (e.g., Established Name)
0..1 genericMedicineEntityWithGeneric
0..1 generic *classCode *: <= GRIC
SubstanceclassCode *: <= MMATdeterminerCode*: <= KINDcode*: CE CWE [0..1] <= EntityCodename*: TN [1..1] (Active or Inactive established name)
ActiveMoietyEntityclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCode (Active moiety code)name*: TN [1..1]
0..1 activeMoietyEntity
ActiveMoiety 0..* activeMoiety
classCode *: <= ACTM
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..* section
componenttypeCode *: <= COMPcontextConductionInd: BL "true"
0..*
author
PackagedMedicineclassCode *: <= CONTdeterminerCode *: <= KINDcode*: CE CWE [1..1] <= PackagedMedication (package product code, e.g., NDC)formCode*: CE CWE [1..1] <= ContainerForm (package type)
0..1 packagedMedicine
SubContent
0..* content
classCode *: <= CONT(cpd product pkgs)quantity*: RTO<PQ,PQ>(Package Quantity)
PolicyclassCode *: <= ACTmoodCode *: <= EVNcode *: CE CNE [1..1] <=RegulationPolicyActCode (DEA schedule, Rx vs. OTC)
AdditionalInformation
0..*
subject
MedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= DrugEntityname*: TN [1..1] (Proprietary name)formCode*: CE CWE [0..1] <= MaterialForm (Dosage form)
0..1 substance
ActiveIngredient0..* activeIngredient
classCode *: <= ACTIquantity*: RTO<PQ,PQ> [0..1] (Strength)
1..1 medicine *
MedicinePart 0..* part
classCode *: <= PARTquantity: RTO<PQ,PQ> [0..1]
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
0..* substanceAdministration
typeCode*: <= CSM
consumedIn0..1 medicine
ManufacturedProductclassCode *: <= MANUid: II [0..1]
0..1 substance
InactiveIngredient0..* inactiveIngredient
classCode *: <= IACTquantity: RTO<PQ,PQ>
0..* manufacturedProduct
typeCode *: <= SBJ
subject
0..* substanceAdministration
typeCode*: <= CSM
consumedIn
SubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministration
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFeffectiveTime: GTS [0..1]routeCode: CE CWE [0..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <= RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value*: ANY [0..1] (SET<PQ> or CE)
OtherIssueSubject
0..* otherIssueSubject *
typeCode*: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode*: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode*: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode*: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode*: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime*: GTS [0..1]repeatNumber*: IVL<INT> [0..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode*: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRT (adverse event, interaction with drug or food, caution, ...)moodCode *: <= DEFcode*: CD CWE [0..1] <= Issue (further specification of issue concept, if applicable)text: ED [0..1]
0..* monitoringObservation
typeCode *: <= INST
definition
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime*: GTS [0..1]repeatNumber*: IVL<INT> [0..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: ED [0..1]effectiveTime*: IVL<TS> [0..1]
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode*: <= RSON
reason
PharmaceuticalClassclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode
ApprovalclassCode *: <= CNTRCTmoodCode *: <= EVNid *: II [1..1] (e.g., NDA number)code*: CE CWE [0..1] <= ActMedicineApprovalstatusCode*: CS CNE [0..1] <= ActStatus (active: not yet approved; complete:approved; obsolete: withdrawn)
0..1 country *0..1 governingAgency
TerritorialAuthorityclassCode *: <= TERR
CountryclassCode *: <= STATEdeterminerCode *: <= INSTANCEcode *: CE CWE [1..1] <= CountryCodename: TN [0..1] (country name if not coded)
AgencyclassCode *: <= PUBdeterminerCode*: <= INSTANCEid*: II [0..1]name*: ON [0..1] (e.g., the FDA for the USA)
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (CE, SET of CE or IVL ofPQ)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
1..1 medicineClass *
SpecializedKind0..* generalization
1..1 pharmaceuticalClass *
SpecializedKind0..* generalization1
classCode *: <= GEN
1..1 medicineClass *SpecializedKind
0..* generalization
1..1 territorialAuthority *
typeCode *: <= AUTtime*: TS [0..1] (time approval was granted)
author
0..* substanceAdministration
typeCode *: <= SUBJ
subject
0..* additionalInformationtypeCode*: <= SBJ
subjectOf
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
LEVEL 1
LEVEL 2
0..1 containingPackagedMedicine
Content
0..* container
classCode *: <= CONTquantity*: RTO<PQ,PQ> [1..1](Packaged Drug Quantity)
Document, Section,
Product Description and Listing Information
Prescribing Information:
Indication,Dosage & AdministrationContraindications,Interactions,Adverse Effects, Cautions,Monitoring
41
SPL V2b Subgroup, Feb 2005
SPL r2 Document and Product Description
0..* sectionReplaced
typeCode*: <= RPLCcontextConductionInd: BL "false"
replacementOf
0..1 highlight
typeCode*: <= XCRPT
excerpt
CharacteristicclassCode *: <= OBSmoodCode *: <= EVNcode*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]value*: ANY [0..1]
SPL_RMIM_LEVEL_2(PORR_RM050024)
This shared RMIM is used forproduct labeling, such as the humanprescription drug labeling
DocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]code *: CE CWE [1..1] <=DocumentTypetitle: ST [0..1]effectiveTime *: TS [1..1]availabilityTime: TS [0..1] (Releasedate)confidentialityCode: CE CWE [0..1] <= ConfidentialityByAccessKindlanguageCode: CS CNE [0..1] <=HumanLanguagesetId: II [0..1]versionNumber: INT [0..1]
ObservationMediaclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]value *: ED [1..1]
NonXMLBodyclassCode *: <= DOCBODYmoodCode *: <= EVNtext *: ED [1..1]
StructuredBodyclassCode *: <= DOCBODYmoodCode *: <= EVN
ObservationclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]confidentialityCode*: CE CWE [0..1] <= ConfidentialityByAccessKindvalue*: ANY [0..1]
0..1 person
0..1 representedOrganization
AssignedEntityclassCode *: <= ASSIGNEDid*: II [0..1]addr: AD [0..1]telecom: BAG<TEL> [0..*]
PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname*: BAG<PN> [0..*]
OrganizationclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [0..1]name*: ON [0..1]telecom: TEL [0..1]addr: AD [0..1]
0..* assignedEntity
verifiertypeCode*: <= VRF (reviewer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
RelatedDocumentclassCode *: <= DOCmoodCode *: <= EVNid*: II [1..1]setId: II [0..1]versionNumber: INT [0..1]
0..* relatedDocument
typeCode *: <= x_ActRelationshipDocumentcontextConductionInd: BL "false"
relatedDocument
0..* assignedEntity
legalAuthenticatortypeCode*: <= LA (legal authenticator at manufacturer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
0..* assignedEntity
authortypeCode*: <= AUT (author at manufacturer)contextControlCode: CS CNE [0..1] <= "OP"time *: TS [1..1]
SectionComponent
component
0..* sectionComponent
typeCode*: <= COMPcontextConductionInd: BL [0..1] "true"
1..1 documentBodyChoice
componenttypeCode *: <= COMPcontextConductionInd: BL "true"
DocumentBodyChoice
SectionReplacedclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]
GenericMedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode: CE CWE <= DrugEntityname*: TN [1..1] (e.g., Established Name)
0..1 genericMedicineEntityWithGeneric
0..* genericclassCode *: <= GRIC
SubstanceclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCodename*: TN [1..1] (Active or Inactive established name)
ActiveMoietyEntityclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCode (Active moiety code)name*: TN [1..1]
0..1 activeMoietyEntity
ActiveMoiety 0..* activeMoiety
classCode *: <= ACTM
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..1 containingPackagedMedicine
Content
0..* container
classCode *: <= CONTquantity*: RTO<PQ,PQ> [1..1](Packaged Drug Quantity)
0..* section
componenttypeCode*: <= COMPcontextConductionInd: BL "true"
0..*author
PackagedMedicineclassCode *: <= CONTdeterminerCode *: <= KINDcode*: CE CWE [1..1] <= PackagedMedication (package product code, e.g., NDC)formCode*: CE CWE [1..1] <= ContainerForm (package type)
0..1 packagedMedicine
SubContent
0..* content
classCode *: <= CONT(cpd product pkgs)quantity*: RTO<PQ,PQ>(Package Quantity)
PolicyclassCode *: <= ACTmoodCode *: <= EVNcode *: CE CNE [1..1] <=RegulationPolicyActCode (DEA schedule, Rx vs. OTC)
AdditionalInformation
0..*
subject
MedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= DrugEntityname*: TN [1..1] (Proprietary name)formCode*: CE CWE [0..1] <= MaterialForm (Dosage form)
0..1 substance
ActiveIngredient0..* activeIngredient
classCode *: <= ACTIquantity*: RTO<PQ,PQ> [0..1] (Strength)
1..1 medicine *
MedicinePart 0..* part
classCode *: <= PARTquantity: RTO<PQ,PQ> [0..1]
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
0..* substanceAdministration
typeCode *: <= CSM
consumedIn0..1 medicine
ManufacturedProductclassCode *: <= MANUid: II [0..1]
0..1 substance
InactiveIngredient0..* inactiveIngredient
classCode *: <= IACTquantity: RTO<PQ,PQ>
0..* manufacturedProduct
typeCode *: <= SBJ
subject
0..* substanceAdministration
typeCode *: <= CSM
consumedIn
SubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFrouteCode*: CE CWE [1..1] <= RouteOfAdministration
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
PharmaceuticalClassclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode
ApprovalclassCode *: <= CNTRCTmoodCode *: <= EVNid*: II [1..1] (e.g., NDA number)code*: CE CWE [0..1] <= ActMedicineApprovalstatusCode*: CS CNE [0..1] <= ActStatus (active: not yet approved; complete:approved; obsolete: withdrawn)
0..1 country *0..1 governingAgency
TerritorialAuthorityclassCode *: <= TERR
CountryclassCode *: <= STATEdeterminerCode *: <= INSTANCEcode *: CE CWE [1..1] <= CountryCodename: TN [0..1] (country name if not coded)
AgencyclassCode *: <= PUBdeterminerCode *: <= INSTANCEid*: II [0..1]name*: ON [0..1] (e.g., the FDA for the USA)
1..1 medicineClass *
SpecializedKind0..* generalization
1..1 pharmaceuticalClass *
SpecializedKind0..* generalization
classCode *: <= GEN
1..1 medicineClass *SpecializedKind
0..* generalization
1..1 territorialAuthority *
typeCode*: <= AUTtime*: TS [0..1] (time approval was granted)
author
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
42
SPL V2b Subgroup, Feb 2005
SPL r2 Document, Section, Highlight (Excerpt)
0..* sectionReplaced
typeCode*: <= RPLCcontextConductionInd: BL "false"
replacementOf
0..1 highlight
typeCode*: <= XCRPT
excerpt
SPL_RMIM_LEVEL_2(PORR_RM050024)
This shared RMIM is used forproduct labeling, such as the humanprescription drug labeling
DocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]code *: CE CWE [1..1] <=DocumentTypetitle: ST [0..1]effectiveTime *: TS [1..1]availabilityTime: TS [0..1] (Releasedate)confidentialityCode: CE CWE [0..1] <= ConfidentialityByAccessKindlanguageCode: CS CNE [0..1] <=HumanLanguagesetId: II [0..1]versionNumber: INT [0..1]
ObservationMediaclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]value *: ED [1..1]
NonXMLBodyclassCode *: <= DOCBODYmoodCode *: <= EVNtext *: ED [1..1]
StructuredBodyclassCode *: <= DOCBODYmoodCode *: <= EVN
ObservationclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]confidentialityCode*: CE CWE [0..1] <= ConfidentialityByAccessKindvalue*: ANY [0..1]
0..1 person
0..1 representedOrganization
AssignedEntityclassCode *: <= ASSIGNEDid*: II [0..1]addr: AD [0..1]telecom: BAG<TEL> [0..*]
PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname*: BAG<PN> [0..*]
OrganizationclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [0..1]name*: ON [0..1]telecom: TEL [0..1]addr: AD [0..1]
0..* assignedEntity
verifiertypeCode*: <= VRF (reviewer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
RelatedDocumentclassCode *: <= DOCmoodCode *: <= EVNid*: II [1..1]setId: II [0..1]versionNumber: INT [0..1]
0..* relatedDocument
typeCode *: <= x_ActRelationshipDocumentcontextConductionInd: BL "false"
relatedDocument
0..* assignedEntity
legalAuthenticatortypeCode*: <= LA (legal authenticator at manufacturer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
0..* assignedEntity
authortypeCode*: <= AUT (author at manufacturer)contextControlCode: CS CNE [0..1] <= "OP"time *: TS [1..1]
SectionComponent
component
0..* sectionComponent
typeCode*: <= COMPcontextConductionInd: BL [0..1] "true"
1..1 documentBodyChoice
componenttypeCode *: <= COMPcontextConductionInd: BL "true"
DocumentBodyChoice
SectionReplacedclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..* section
componenttypeCode*: <= COMPcontextConductionInd: BL "true"
0..*author
0..*
subject
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
43
SPL V2b Subgroup, Feb 2005
SPL r2 Document and Product Description
0..* sectionReplaced
typeCode*: <= RPLCcontextConductionInd: BL "false"
replacementOf
0..1 highlight
typeCode*: <= XCRPT
excerpt
CharacteristicclassCode *: <= OBSmoodCode *: <= EVNcode*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]value*: ANY [0..1]
SPL_RMIM_LEVEL_2(PORR_RM050024)
This shared RMIM is used forproduct labeling, such as the humanprescription drug labeling
DocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]code *: CE CWE [1..1] <=DocumentTypetitle: ST [0..1]effectiveTime *: TS [1..1]availabilityTime: TS [0..1] (Releasedate)confidentialityCode: CE CWE [0..1] <= ConfidentialityByAccessKindlanguageCode: CS CNE [0..1] <=HumanLanguagesetId: II [0..1]versionNumber: INT [0..1]
ObservationMediaclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]value *: ED [1..1]
NonXMLBodyclassCode *: <= DOCBODYmoodCode *: <= EVNtext *: ED [1..1]
StructuredBodyclassCode *: <= DOCBODYmoodCode *: <= EVN
ObservationclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]confidentialityCode*: CE CWE [0..1] <= ConfidentialityByAccessKindvalue*: ANY [0..1]
0..1 person
0..1 representedOrganization
AssignedEntityclassCode *: <= ASSIGNEDid*: II [0..1]addr: AD [0..1]telecom: BAG<TEL> [0..*]
PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname*: BAG<PN> [0..*]
OrganizationclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [0..1]name*: ON [0..1]telecom: TEL [0..1]addr: AD [0..1]
0..* assignedEntity
verifiertypeCode*: <= VRF (reviewer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
RelatedDocumentclassCode *: <= DOCmoodCode *: <= EVNid*: II [1..1]setId: II [0..1]versionNumber: INT [0..1]
0..* relatedDocument
typeCode *: <= x_ActRelationshipDocumentcontextConductionInd: BL "false"
relatedDocument
0..* assignedEntity
legalAuthenticatortypeCode*: <= LA (legal authenticator at manufacturer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
0..* assignedEntity
authortypeCode*: <= AUT (author at manufacturer)contextControlCode: CS CNE [0..1] <= "OP"time *: TS [1..1]
SectionComponent
component
0..* sectionComponent
typeCode*: <= COMPcontextConductionInd: BL [0..1] "true"
1..1 documentBodyChoice
componenttypeCode *: <= COMPcontextConductionInd: BL "true"
DocumentBodyChoice
SectionReplacedclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]
GenericMedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode: CE CWE <= DrugEntityname*: TN [1..1] (e.g., Established Name)
0..1 genericMedicineEntityWithGeneric
0..* genericclassCode *: <= GRIC
SubstanceclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCodename*: TN [1..1] (Active or Inactive established name)
ActiveMoietyEntityclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCode (Active moiety code)name*: TN [1..1]
0..1 activeMoietyEntity
ActiveMoiety 0..* activeMoiety
classCode *: <= ACTM
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..1 containingPackagedMedicine
Content
0..* container
classCode *: <= CONTquantity*: RTO<PQ,PQ> [1..1](Packaged Drug Quantity)
0..* section
componenttypeCode*: <= COMPcontextConductionInd: BL "true"
0..*author
PackagedMedicineclassCode *: <= CONTdeterminerCode *: <= KINDcode*: CE CWE [1..1] <= PackagedMedication (package product code, e.g., NDC)formCode*: CE CWE [1..1] <= ContainerForm (package type)
0..1 packagedMedicine
SubContent
0..* content
classCode *: <= CONT(cpd product pkgs)quantity*: RTO<PQ,PQ>(Package Quantity)
PolicyclassCode *: <= ACTmoodCode *: <= EVNcode *: CE CNE [1..1] <=RegulationPolicyActCode (DEA schedule, Rx vs. OTC)
AdditionalInformation
0..*
subject
MedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= DrugEntityname*: TN [1..1] (Proprietary name)formCode*: CE CWE [0..1] <= MaterialForm (Dosage form)
0..1 substance
ActiveIngredient0..* activeIngredient
classCode *: <= ACTIquantity*: RTO<PQ,PQ> [0..1] (Strength)
1..1 medicine *
MedicinePart 0..* part
classCode *: <= PARTquantity: RTO<PQ,PQ> [0..1]
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
0..* substanceAdministration
typeCode *: <= CSM
consumedIn0..1 medicine
ManufacturedProductclassCode *: <= MANUid: II [0..1]
0..1 substance
InactiveIngredient0..* inactiveIngredient
classCode *: <= IACTquantity: RTO<PQ,PQ>
0..* manufacturedProduct
typeCode *: <= SBJ
subject
0..* substanceAdministration
typeCode *: <= CSM
consumedIn
SubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFrouteCode*: CE CWE [1..1] <= RouteOfAdministration
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
PharmaceuticalClassclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode
ApprovalclassCode *: <= CNTRCTmoodCode *: <= EVNid*: II [1..1] (e.g., NDA number)code*: CE CWE [0..1] <= ActMedicineApprovalstatusCode*: CS CNE [0..1] <= ActStatus (active: not yet approved; complete:approved; obsolete: withdrawn)
0..1 country *0..1 governingAgency
TerritorialAuthorityclassCode *: <= TERR
CountryclassCode *: <= STATEdeterminerCode *: <= INSTANCEcode *: CE CWE [1..1] <= CountryCodename: TN [0..1] (country name if not coded)
AgencyclassCode *: <= PUBdeterminerCode *: <= INSTANCEid*: II [0..1]name*: ON [0..1] (e.g., the FDA for the USA)
1..1 medicineClass *
SpecializedKind0..* generalization
1..1 pharmaceuticalClass *
SpecializedKind0..* generalization
classCode *: <= GEN
1..1 medicineClass *SpecializedKind
0..* generalization
1..1 territorialAuthority *
typeCode*: <= AUTtime*: TS [0..1] (time approval was granted)
author
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
44
SPL V2b Subgroup, Feb 2005
SPL r2 Product Description (Listing Information)
CharacteristicclassCode *: <= OBSmoodCode *: <= EVNcode*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]value*: ANY [0..1]
GenericMedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode: CE CWE <= DrugEntityname*: TN [1..1] (e.g., Established Name)
0..1 genericMedicineEntityWithGeneric
0..* genericclassCode *: <= GRIC
SubstanceclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCodename*: TN [1..1] (Active or Inactive established name)
ActiveMoietyEntityclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCode (Active moiety code)name*: TN [1..1]
0..1 activeMoietyEntity
ActiveMoiety 0..* activeMoiety
classCode *: <= ACTM
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..1 containingPackagedMedicine
Content
0..* container
classCode *: <= CONTquantity*: RTO<PQ,PQ> [1..1](Packaged Drug Quantity)
PackagedMedicineclassCode *: <= CONTdeterminerCode *: <= KINDcode*: CE CWE [1..1] <= PackagedMedication (package product code, e.g., NDC)formCode*: CE CWE [1..1] <= ContainerForm (package type)
0..1 packagedMedicine
SubContent
0..* content
classCode *: <= CONT(cpd product pkgs)quantity*: RTO<PQ,PQ>(Package Quantity)
PolicyclassCode *: <= ACTmoodCode *: <= EVNcode *: CE CNE [1..1] <=RegulationPolicyActCode (DEA schedule, Rx vs. OTC)
AdditionalInformation
MedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= DrugEntityname*: TN [1..1] (Proprietary name)formCode*: CE CWE [0..1] <= MaterialForm (Dosage form)
0..1 substance
ActiveIngredient0..* activeIngredient
classCode *: <= ACTIquantity*: RTO<PQ,PQ> [0..1] (Strength)
1..1 medicine *
MedicinePart 0..* part
classCode *: <= PARTquantity: RTO<PQ,PQ> [0..1]
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
0..* substanceAdministration
typeCode *: <= CSM
consumedIn0..1 medicine
ManufacturedProductclassCode *: <= MANUid: II [0..1]
0..1 substance
InactiveIngredient0..* inactiveIngredient
classCode *: <= IACTquantity: RTO<PQ,PQ>
0..* manufacturedProduct
typeCode *: <= SBJ
subject
0..* substanceAdministration
typeCode *: <= CSM
consumedIn
SubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFrouteCode*: CE CWE [1..1] <= RouteOfAdministration
PharmaceuticalClassclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode
ApprovalclassCode *: <= CNTRCTmoodCode *: <= EVNid*: II [1..1] (e.g., NDA number)code*: CE CWE [0..1] <= ActMedicineApprovalstatusCode*: CS CNE [0..1] <= ActStatus (active: not yet approved; complete:approved; obsolete: withdrawn)
0..1 country *0..1 governingAgency
TerritorialAuthorityclassCode *: <= TERR
CountryclassCode *: <= STATEdeterminerCode *: <= INSTANCEcode *: CE CWE [1..1] <= CountryCodename: TN [0..1] (country name if not coded)
AgencyclassCode *: <= PUBdeterminerCode *: <= INSTANCEid*: II [0..1]name*: ON [0..1] (e.g., the FDA for the USA)
1..1 medicineClass *
SpecializedKind0..* generalization
1..1 pharmaceuticalClass *
SpecializedKind0..* generalization
classCode *: <= GEN
1..1 medicineClass *SpecializedKind
0..* generalization
1..1 territorialAuthority *
typeCode*: <= AUTtime*: TS [0..1] (time approval was granted)
author
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
45
SPL V2b Subgroup, Feb 2005
SPL r2 Document and Listing Information
0..* sectionReplaced
typeCode*: <= RPLCcontextConductionInd: BL "false"
replacementOf
0..1 highlight
typeCode*: <= XCRPT
excerpt
CharacteristicclassCode *: <= OBSmoodCode *: <= EVNcode*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]value*: ANY [0..1]
SPL_RMIM_LEVEL_2(PORR_RM050024)
This shared RMIM is used forproduct labeling, such as the humanprescription drug labeling
DocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]code *: CE CWE [1..1] <=DocumentTypetitle: ST [0..1]effectiveTime *: TS [1..1]availabilityTime: TS [0..1] (Releasedate)confidentialityCode: CE CWE [0..1] <= ConfidentialityByAccessKindlanguageCode: CS CNE [0..1] <=HumanLanguagesetId: II [0..1]versionNumber: INT [0..1]
ObservationMediaclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]value *: ED [1..1]
NonXMLBodyclassCode *: <= DOCBODYmoodCode *: <= EVNtext *: ED [1..1]
StructuredBodyclassCode *: <= DOCBODYmoodCode *: <= EVN
ObservationclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]confidentialityCode*: CE CWE [0..1] <= ConfidentialityByAccessKindvalue*: ANY [0..1]
0..1 person
0..1 representedOrganization
AssignedEntityclassCode *: <= ASSIGNEDid*: II [0..1]addr: AD [0..1]telecom: BAG<TEL> [0..*]
PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname*: BAG<PN> [0..*]
OrganizationclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [0..1]name*: ON [0..1]telecom: TEL [0..1]addr: AD [0..1]
0..* assignedEntity
verifiertypeCode*: <= VRF (reviewer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
RelatedDocumentclassCode *: <= DOCmoodCode *: <= EVNid*: II [1..1]setId: II [0..1]versionNumber: INT [0..1]
0..* relatedDocument
typeCode *: <= x_ActRelationshipDocumentcontextConductionInd: BL "false"
relatedDocument
0..* assignedEntity
legalAuthenticatortypeCode*: <= LA (legal authenticator at manufacturer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
0..* assignedEntity
authortypeCode*: <= AUT (author at manufacturer)contextControlCode: CS CNE [0..1] <= "OP"time *: TS [1..1]
SectionComponent
component
0..* sectionComponent
typeCode*: <= COMPcontextConductionInd: BL [0..1] "true"
1..1 documentBodyChoice
componenttypeCode *: <= COMPcontextConductionInd: BL "true"
DocumentBodyChoice
SectionReplacedclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]
GenericMedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode: CE CWE <= DrugEntityname*: TN [1..1] (e.g., Established Name)
0..1 genericMedicineEntityWithGeneric
0..* genericclassCode *: <= GRIC
SubstanceclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCodename*: TN [1..1] (Active or Inactive established name)
ActiveMoietyEntityclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCode (Active moiety code)name*: TN [1..1]
0..1 activeMoietyEntity
ActiveMoiety 0..* activeMoiety
classCode *: <= ACTM
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..1 containingPackagedMedicine
Content
0..* container
classCode *: <= CONTquantity*: RTO<PQ,PQ> [1..1](Packaged Drug Quantity)
0..* section
componenttypeCode*: <= COMPcontextConductionInd: BL "true"
0..*author
PackagedMedicineclassCode *: <= CONTdeterminerCode *: <= KINDcode*: CE CWE [1..1] <= PackagedMedication (package product code, e.g., NDC)formCode*: CE CWE [1..1] <= ContainerForm (package type)
0..1 packagedMedicine
SubContent
0..* content
classCode *: <= CONT(cpd product pkgs)quantity*: RTO<PQ,PQ>(Package Quantity)
PolicyclassCode *: <= ACTmoodCode *: <= EVNcode *: CE CNE [1..1] <=RegulationPolicyActCode (DEA schedule, Rx vs. OTC)
AdditionalInformation
0..*
subject
MedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= DrugEntityname*: TN [1..1] (Proprietary name)formCode*: CE CWE [0..1] <= MaterialForm (Dosage form)
0..1 substance
ActiveIngredient0..* activeIngredient
classCode *: <= ACTIquantity*: RTO<PQ,PQ> [0..1] (Strength)
1..1 medicine *
MedicinePart 0..* part
classCode *: <= PARTquantity: RTO<PQ,PQ> [0..1]
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
0..* substanceAdministration
typeCode *: <= CSM
consumedIn0..1 medicine
ManufacturedProductclassCode *: <= MANUid: II [0..1]
0..1 substance
InactiveIngredient0..* inactiveIngredient
classCode *: <= IACTquantity: RTO<PQ,PQ>
0..* manufacturedProduct
typeCode *: <= SBJ
subject
0..* substanceAdministration
typeCode *: <= CSM
consumedIn
SubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFrouteCode*: CE CWE [1..1] <= RouteOfAdministration
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
PharmaceuticalClassclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode
ApprovalclassCode *: <= CNTRCTmoodCode *: <= EVNid*: II [1..1] (e.g., NDA number)code*: CE CWE [0..1] <= ActMedicineApprovalstatusCode*: CS CNE [0..1] <= ActStatus (active: not yet approved; complete:approved; obsolete: withdrawn)
0..1 country *0..1 governingAgency
TerritorialAuthorityclassCode *: <= TERR
CountryclassCode *: <= STATEdeterminerCode *: <= INSTANCEcode *: CE CWE [1..1] <= CountryCodename: TN [0..1] (country name if not coded)
AgencyclassCode *: <= PUBdeterminerCode *: <= INSTANCEid*: II [0..1]name*: ON [0..1] (e.g., the FDA for the USA)
1..1 medicineClass *
SpecializedKind0..* generalization
1..1 pharmaceuticalClass *
SpecializedKind0..* generalization
classCode *: <= GEN
1..1 medicineClass *SpecializedKind
0..* generalization
1..1 territorialAuthority *
typeCode*: <= AUTtime*: TS [0..1] (time approval was granted)
author
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
46
SPL V2b Subgroup, Feb 2005
SPL r2 Overview (10000 ft)
0..* sectionReplaced
typeCode*: <= RPLCcontextConductionInd: BL "false"
replacementOf
0..1 highlight
typeCode *: <= XCRPT
excerpt
CharacteristicclassCode *: <= OBSmoodCode *: <= EVNcode*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]value*: ANY [0..1]
SPL_RMIM_LEVEL_2(PORR_RM050024)
This shared RMIM is used forproduct labeling, such as the humanprescription drug labeling
DocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]code *: CE CWE [1..1] <=DocumentTypetitle: ST [0..1]effectiveTime *: TS [1..1]availabilityTime: TS [0..1] (Releasedate)confidentialityCode: CE CWE [0..1] <= ConfidentialityByAccessKindlanguageCode: CS CNE [0..1] <=HumanLanguagesetId: II [0..1]versionNumber: INT [0..1]
ObservationMediaclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]value *: ED [1..1]
NonXMLBodyclassCode *: <= DOCBODYmoodCode *: <= EVNtext *: ED [1..1]
StructuredBodyclassCode *: <= DOCBODYmoodCode *: <= EVN
ObservationclassCode *: <= OBSmoodCode *: <= EVNid: II [0..1]code*: CE CWE [1..1] <= ObservationTypetext: ED [0..1]confidentialityCode*: CE CWE [0..1] <= ConfidentialityByAccessKindvalue*: ANY [0..1]
0..1 person
0..1 representedOrganization
AssignedEntityclassCode *: <= ASSIGNEDid*: II [0..1]addr: AD [0..1]telecom: BAG<TEL> [0..*]
PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname*: BAG<PN> [0..*]
OrganizationclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [0..1]name*: ON [0..1]telecom: TEL [0..1]addr: AD [0..1]
0..* assignedEntity
verifiertypeCode*: <= VRF (reviewer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
RelatedDocumentclassCode *: <= DOCmoodCode *: <= EVNid *: II [1..1]setId: II [0..1]versionNumber: INT [0..1]
0..* relatedDocument
typeCode*: <= x_ActRelationshipDocumentcontextConductionInd: BL "false"
relatedDocument
0..* assignedEntity
legalAuthenticatortypeCode*: <= LA (legal authenticator at manufacturer)time *: TS [1..1]signatureCode: CS CNE [0..1] <= ParticipationSignature "S"
0..* assignedEntity
authortypeCode*: <= AUT (author at manufacturer)contextControlCode: CS CNE [0..1] <= "OP"time *: TS [1..1]
SectionComponent
component
0..* sectionComponent
typeCode*: <= COMPcontextConductionInd: BL [0..1] "true"
1..1 documentBodyChoice
componenttypeCode*: <= COMPcontextConductionInd: BL "true"
DocumentBodyChoice
SectionReplacedclassCode *: <= DOCSECTmoodCode *: <= EVNid*: II [1..1]
GenericMedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode: CE CWE <= DrugEntityname*: TN [1..1] (e.g., Established Name)
0..1 genericMedicineEntityWithGeneric
0..1 generic *classCode *: <= GRIC
SubstanceclassCode *: <= MMATdeterminerCode*: <= KINDcode*: CE CWE [0..1] <= EntityCodename*: TN [1..1] (Active or Inactive established name)
ActiveMoietyEntityclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= EntityCode (Active moiety code)name*: TN [1..1]
0..1 activeMoietyEntity
ActiveMoiety 0..* activeMoiety
classCode *: <= ACTM
SectionclassCode *: <= DOCSECTmoodCode *: <= EVNid *: II [1..1]code*: CE CWE [0..1] <= DocumentSectionTypetitle*: ST [0..1]text*: ED [0..1] (special hand-crafted content model)effectiveTime: IVL<TS> [0..1]confidentialityCode: CE CWE [0..1] <= ConfidentialitylanguageCode: CS CNE [0..1] <= HumanLanguage
0..* section
componenttypeCode *: <= COMPcontextConductionInd: BL "true"
0..*
author
PackagedMedicineclassCode *: <= CONTdeterminerCode *: <= KINDcode*: CE CWE [1..1] <= PackagedMedication (package product code, e.g., NDC)formCode*: CE CWE [1..1] <= ContainerForm (package type)
0..1 packagedMedicine
SubContent
0..* content
classCode *: <= CONT(cpd product pkgs)quantity*: RTO<PQ,PQ>(Package Quantity)
PolicyclassCode *: <= ACTmoodCode *: <= EVNcode *: CE CNE [1..1] <=RegulationPolicyActCode (DEA schedule, Rx vs. OTC)
AdditionalInformation
0..*
subject
MedicineclassCode *: <= MMATdeterminerCode *: <= KINDcode*: CE CWE [0..1] <= DrugEntityname*: TN [1..1] (Proprietary name)formCode*: CE CWE [0..1] <= MaterialForm (Dosage form)
0..1 substance
ActiveIngredient0..* activeIngredient
classCode *: <= ACTIquantity*: RTO<PQ,PQ> [0..1] (Strength)
1..1 medicine *
MedicinePart 0..* part
classCode *: <= PARTquantity: RTO<PQ,PQ> [0..1]
0..* additionalInformationtypeCode *: <= SBJ
subjectOf
0..* substanceAdministration
typeCode*: <= CSM
consumedIn0..1 medicine
ManufacturedProductclassCode *: <= MANUid: II [0..1]
0..1 substance
InactiveIngredient0..* inactiveIngredient
classCode *: <= IACTquantity: RTO<PQ,PQ>
0..* manufacturedProduct
typeCode *: <= SBJ
subject
0..* substanceAdministration
typeCode*: <= CSM
consumedIn
SubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministration
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFeffectiveTime: GTS [0..1]routeCode: CE CWE [0..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <= RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value*: ANY [0..1] (SET<PQ> or CE)
OtherIssueSubject
0..* otherIssueSubject *
typeCode*: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode*: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode*: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode*: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode*: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime*: GTS [0..1]repeatNumber*: IVL<INT> [0..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode*: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRT (adverse event, interaction with drug or food, caution, ...)moodCode *: <= DEFcode*: CD CWE [0..1] <= Issue (further specification of issue concept, if applicable)text: ED [0..1]
0..* monitoringObservation
typeCode *: <= INST
definition
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime*: GTS [0..1]repeatNumber*: IVL<INT> [0..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: ED [0..1]effectiveTime*: IVL<TS> [0..1]
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode*: <= RSON
reason
PharmaceuticalClassclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode
ApprovalclassCode *: <= CNTRCTmoodCode *: <= EVNid *: II [1..1] (e.g., NDA number)code*: CE CWE [0..1] <= ActMedicineApprovalstatusCode*: CS CNE [0..1] <= ActStatus (active: not yet approved; complete:approved; obsolete: withdrawn)
0..1 country *0..1 governingAgency
TerritorialAuthorityclassCode *: <= TERR
CountryclassCode *: <= STATEdeterminerCode *: <= INSTANCEcode *: CE CWE [1..1] <= CountryCodename: TN [0..1] (country name if not coded)
AgencyclassCode *: <= PUBdeterminerCode*: <= INSTANCEid*: II [0..1]name*: ON [0..1] (e.g., the FDA for the USA)
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (CE, SET of CE or IVL ofPQ)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
1..1 medicineClass *
SpecializedKind0..* generalization
1..1 pharmaceuticalClass *
SpecializedKind0..* generalization1
classCode *: <= GEN
1..1 medicineClass *SpecializedKind
0..* generalization
1..1 territorialAuthority *
typeCode *: <= AUTtime*: TS [0..1] (time approval was granted)
author
0..* substanceAdministration
typeCode *: <= SUBJ
subject
0..* additionalInformationtypeCode*: <= SBJ
subjectOf
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
LEVEL 1
LEVEL 2
0..1 containingPackagedMedicine
Content
0..* container
classCode *: <= CONTquantity*: RTO<PQ,PQ> [1..1](Packaged Drug Quantity)
Prescribing Information:
Indication,Dosage & AdministrationContraindications,Interactions,Adverse Effects, Cautions,Monitoring
47
SPL V2b Subgroup, Feb 2005
SPL r2 Clinical Product Information
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <=RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value *: CE CWE [1..1] <= ObservationValue
OtherIssueSubject
0..* otherIssueSubject *
typeCode *: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode *: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode *: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode *: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRTmoodCode *: <= DEFcode *: CD CWE [1..1] <= x_ClinicalEffectsCategory (adverse event, interaction with drug or food, caution, ...)
0..* monitoringObservation
typeCode *: <= INST
definition
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (1..* SET<ANY> [1..1](1..*, SET of PQ, CE)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..* substanceAdministration
typeCode *: <= SUBJ
subject
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
48
SPL V2b Subgroup, Feb 2005
SPL r2 Indication and Dosage
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
49
SPL V2b Subgroup, Feb 2005
SPL r2 Clinical Product Information
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <=RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value *: CE CWE [1..1] <= ObservationValue
OtherIssueSubject
0..* otherIssueSubject *
typeCode *: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode *: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode *: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode *: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRTmoodCode *: <= DEFcode *: CD CWE [1..1] <= x_ClinicalEffectsCategory (adverse event, interaction with drug or food, caution, ...)
0..* monitoringObservation
typeCode *: <= INST
definition
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (1..* SET<ANY> [1..1](1..*, SET of PQ, CE)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..* substanceAdministration
typeCode *: <= SUBJ
subject
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
50
SPL V2b Subgroup, Feb 2005
SPL r2 Contraindication, Interaction, Caution
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <=RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value *: CE CWE [1..1] <= ObservationValue
OtherIssueSubject
0..* otherIssueSubject *
typeCode *: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode *: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRTmoodCode *: <= DEFcode *: CD CWE [1..1] <= x_ClinicalEffectsCategory (adverse event, interaction with drug or food, caution, ...)
0..* monitoringObservation
typeCode *: <= INST
definition
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (1..* SET<ANY> [1..1](1..*, SET of PQ, CE)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
51
SPL V2b Subgroup, Feb 2005
SPL r2 Clinical Product Information
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <=RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value *: CE CWE [1..1] <= ObservationValue
OtherIssueSubject
0..* otherIssueSubject *
typeCode *: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode *: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode *: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode *: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRTmoodCode *: <= DEFcode *: CD CWE [1..1] <= x_ClinicalEffectsCategory (adverse event, interaction with drug or food, caution, ...)
0..* monitoringObservation
typeCode *: <= INST
definition
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (1..* SET<ANY> [1..1](1..*, SET of PQ, CE)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..* substanceAdministration
typeCode *: <= SUBJ
subject
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
52
SPL V2b Subgroup, Feb 2005
SPL r2 Monitoring
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value *: CE CWE [1..1] <= ObservationValue
0..* consequenceObservationtypeCode *: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode *: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode *: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
IssueclassCode *: <= ALRTmoodCode *: <= DEFcode *: CD CWE [1..1] <= x_ClinicalEffectsCategory (adverse event, interaction with drug or food, caution, ...)
0..* monitoringObservation
typeCode *: <= INST
definition
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
53
SPL V2b Subgroup, Feb 2005
SPL r2 Clinical Product Information
SubstanceAdministration2classCode *: <= SBADMmoodCode *: <= DEFrouteCode *: CE CWE [1..1] <= RouteOfAdministrationmaxDoseQuantity*: SET<RTO<PQ,PQ>> [0..*]
0..* issuetypeCode *: <= SUBJ
subjectOf
SubstanceAdministrationCriterionclassCode *: <= SBADMmoodCode *: <= EVN.CRTrouteCode: CE CWE [0..1] <=RouteOfAdministration (labeled route of administration)
ConsequenceObservationclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <=ObservationDiagnosisTypestext: ST [0..1]value *: CE CWE [1..1] <= ObservationValue
OtherIssueSubject
0..* otherIssueSubject *
typeCode *: <= SUBJconjunctionCode: CS CNE <= RelationshipConjunction
subject
0..* consequenceObservationtypeCode *: <= RISK
riskcauseOf
0..* consequenceObservation
typeCode *: <= CAUS
0..2 severityAndFrequency *typeCode *: <= SUBJ
subjectOf
SeverityclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= "SEV"value *: CE [1..1] <= SeverityObservationValue(mild, moderate, severe)
FrequencyclassCode *: <= OBSmoodCode *: <= EVNcode *: CD CWE [1..1] <= ActCode (fixed)value *: CE [1..1] <= SymptomFrequency (e.g., frequent, infrequent)
ClinicalSituationCriterion
0..* clinicalSituationCriterion
typeCode *: <= PRCNconjunctionCode: CS CNE <= RelationshipConjunction
precondition
ProtocolclassCode *: <= ACTmoodCode *: <= DEF
0..1 protocol *typeCode *: <= COMP
componentOf
MonitoringObservationclassCode *: <= OBSmoodCode *: <= DEFcode *: CE CWE [1..1] <= ObservationTypeeffectiveTime*: GTS [0..1]
1..* monitoringObservation *
typeCode *: <= COMP
component
MonitoringObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CE CWE [1..1] <= ObservationTypevalue *: IVL<PQ> [1..1]
0..* monitoringObservationCriterion
typeCode *: <= OBJC
maintenanceGoal
MaintenanceSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..* maintenanceSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "2"
component2
1..1 playingMaterialKind *
aRoleclassCode *: <= ROL
1..1 participant *typeCode *: <= CSM
consumable
IssueclassCode *: <= ALRTmoodCode *: <= DEFcode *: CD CWE [1..1] <= x_ClinicalEffectsCategory (adverse event, interaction with drug or food, caution, ...)
0..* monitoringObservation
typeCode *: <= INST
definition
InitiationSubstanceAdministrationclassCode *: <= SBADMmoodCode *: <= DEFeffectiveTime *: GTS [1..1]repeatNumber *: IVL<INT> [1..1]doseQuantity *: IVL<PQ> [1..1]rateQuantity: IVL<PQ> [0..1]
0..1 initiationSubstanceAdministration *
typeCode *: <= COMPcontextConductionInd *: BL [1..1] "true"sequenceNumber: INT "1"
component1
HighlightclassCode *: <= DOCSECTmoodCode *: <= EVNtext*: EDstatusCode: CS CNE [0..1] <= ActStatus "active" (suspended: do not show; obsolete: withdrawn)
0..1 therapeuticClass *
typeCode *: <= GEN
generalization
TherapeuticClassclassCode *: <= ACTmoodCode *: <= DEFcode *: CE CWE [1..1] <=SubstanceAdministrationClass
IndicationObservationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationDiagnosisTypesvalue *: CE [1..1] <= ObservationValue ("indication name" and code) 0..* indicationObservationCriterion
typeCode *: <= RSON
reason
SeverityAndFrequency
MaterialKindclassCode *: <= MATdeterminerCode *: <= KINDcode *: CE CWE [1..1] <= EntityCode (specific or general type of drug or foodthat interacts)
ClinicalSituationCriterionclassCode *: <= OBSmoodCode *: <= EVN.CRTcode *: CD CWE [1..1] <= ObservationType (sex, age, condition, ...)negationInd: BL [0..1]value *: ANY [1..1] (1..* SET<ANY> [1..1](1..*, SET of PQ, CE)
0..1 participant
typeCode *: <= CSM
consumable
DoseUnitChoice
0..* substanceAdministration
typeCode *: <= SUBJ
subject
0..1 substance
ActiveIngredient
0..1 substance
ManufacturedProduct
