1

SPL V2b Subgroup, Feb 2005

Brief Overview of the Current Draft SPL V2b Specification:

Clinical Product Information Module and Related Features

2

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

754-7239-54 35412358745

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Contraindications

Ajqwh thqwht qkt qktrh trh qk kh kht kqwhklhj h wjth lkqwht kthhkt thj lkthqljkht qlthjsekthqw ekwhhkht jkth qkltjh qlkht qkh kl

• Tju gktrh qwkth qkjg trg t k atrqhtqhtr ht wlh tglfhgkafhgkahl gkhg g ajgh aj gajkgf kajgf akjgh ajgjahgf ajgh ajg fkj gfjgfjkhgf akjdgh fajkgagf a gfasjg asjkgh asjgf ajkgf ajkg jh a

• 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 ?

4

SPL V2b Subgroup, Feb 2005

Before we answer this question …

… let’s have a look at how computers (clinical decision support systems) use CRL.

5

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

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CRL (e.g. Contraindications)

333-5656--1 344444--744

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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

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CRL (e.g. Contraindications)

E-Patient Record (e.g. Diagnoses)

333-5656--1 344444--744

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Match

Use of C-Labeling by Computers

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SPL V2b Subgroup, Feb 2005

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CRL (e.g. Contraindications)

E-Patient Record (e.g. Diagnoses)

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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.

754-7239-54 2424243111 111-31111 1223344332

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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

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1211-76664 7452314577

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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

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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

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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

XING

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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