| POCP_HD050100UV01 A_ProductInformation |
(Link to Excel View) Derived from RMIM: POCP_RM050100UV01 |
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| ProductInformation | |||||||||
| subjectOf [0..*] (Subject) |
Design Comments: Links any of these product informations with the document which contains them. The document would then usually be specified as a brief reference. This allows keeping track of product detail provided by different versions of the product documentation. |
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| choice of Document |
Design Comments: A detailed reference to a document that records information about the product, or that provides additional details of a production, transportation, or investigation act. This may be a reference to a Structured Product Label which specifies the information from which this product had been identified or from where the information had been cited. |
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| or AdditionalInformation | |||||||||
| or Characteristics | |||||||||
| or Storage |
Design Comments: Specifies a suggested manner of storage of the product and the time the product is good to use if stored in this manner (shelf life). The storage conditions (temperature, humidity, etc.) are specified using one storage condition control variables. |
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| Subject |
Design Comments: Links any of these product informations with the document which contains them. The document would then usually be specified as a brief reference. This allows keeping track of product detail provided by different versions of the product documentation. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
Design Comments: Fixed to SUBJ (subject) |
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| document [1..1] (Document) | |||||||||
| Document |
Design Comments: A detailed reference to a document that records information about the product, or that provides additional details of a production, transportation, or investigation act. This may be a reference to a Structured Product Label which specifies the information from which this product had been identified or from where the information had been cited. |
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| classCode [1..1] (M) Document (CS) {CNE:V:ActClassDocument, root= "DOC"} |
Design Comments: The value provided, ACT, indicates that the activity type is a document [from ICSR] |
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| moodCode [1..1] (M) Document (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the document in question already exists. [from ICSR] |
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| id [0..1] Document (II) |
Design Comments: An identifier for the document, e.g., bill of lading ID, product label id. |
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| code [0..1] Document (CD) {CWE:D:DocumentType} |
Design Comments: A coded indication of the document type. |
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| title [0..1] Document (ED) |
Design Comments: The title of the document. |
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| text [0..1] Document (ED) |
Design Comments: A representation of the document, or of its included text. In case of a document reference, this attribute must not be used. Structured product labels are cited by reference using the id, and possibly setId and versionNumber, not by including any text here. |
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| effectiveTime [0..1] Document (IVL<TS>) |
Design Comments: Document origination time, i.e., a timestamp specifying when the document was created and optionally a high boundary indicating when the information seizes to be effective. |
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| confidentialityCode [0..1] Document (CD) {CWE:D:Confidentiality} |
Design Comments: Specify "B" for excluding this document from public data. |
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| languageCode [0..1] Document (CD) {CWE:D:HumanLanguage} |
Design Comments: A code specifying the human language of character data in the product labeling document (whether in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066: Tags for the Identification of Languages, ed. H. Alvestrand, 1995 (http://www.ietf.org/rfc/rfc3066.txt), which obsoletes RFC 1766. Language is a contextual component of SPL, where the value expressed in the header holds true for the entire document, unless overridden by a nested value. [from SPL] |
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| setId [0..1] Document (II) |
Design Comments: An optional globally-unique identifier, that remains constant across all document revisions that derive from a common original document. |
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| versionNumber [0..1] Document (ST) |
Design Comments: An optional version number is incremented for each subsequent version of a document. For example, an original document is the first version of a document, and gets a new globally unique "id" value; it can also contain a new value for "setId" and a value of "versionNumber" set to equal "1". |
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| bibliographicDesignationText [0..1] Document (ED) |
Design Comments: The complete bibliographic designation, e.g. citation as it would appear in a literature reference list. |
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| author [0..1] (Author1) |
Design Comments: The author of the product document. |
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| Inherits associations from ProductInformation | |||||||||
| Author1 |
Design Comments: The author of the product document. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: Fixed to AUT. |
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| assignedEntity2 [1..1] (R_ProductRelatedAssignedEntityUniversal) | |||||||||
| AdditionalInformation | |||||||||
| choice of RegulatoryOversight | |||||||||
| or Management |
Design Comments: A choice of acts mostly defined for the purpose of laying out the model. |
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| Inherits associations from ProductInformation | |||||||||
| RegulatoryOversight | |||||||||
| choice of Approval |
Design Comments: The authorization to manufacture and market a product or substance for a specified purpose. This may be explicit approval granted by a regulatory authority, following a product class specific process, for example, in the U.S. NDA for prescription drugs, BLA for biologics. This may also include blanket authorization granted by regulation for over the counter medicines. |
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| or Policy |
Design Comments: This is used to specify particular regulations or policies such as control drug schedule or local requirements to authorize use. |
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| Inherits associations from ProductInformation | |||||||||
| Approval |
Design Comments: The authorization to manufacture and market a product or substance for a specified purpose. This may be explicit approval granted by a regulatory authority, following a product class specific process, for example, in the U.S. NDA for prescription drugs, BLA for biologics. This may also include blanket authorization granted by regulation for over the counter medicines. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassContract, root= "CNTRCT"} |
Design Comments: The approval is considered a kind of contract (CNTRCT). A contract is defined as an agreement between two or more parties that is subject to contractual law and enforcement. |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..1] Act (II) |
Design Comments: An identifer for the permission to manufacture and market a product. In the U.S. this may be an identifier arising out of one of many approval processes, such as NDA number, BLA number, etc. |
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| code [0..1] Act (CD) {CWE:D:ActProductApprovalType} |
Design Comments: Specifies the kind of approval process followed. For example, in the U.S. this may be the NDA, BLA, IND process. Any specific or generalized approval process code can be used, including one that specifies no more than that this is an approval. |
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| statusCode [0..1] Act (CS) {CNE:V:ActStatus} |
Design Comments: Tells whether approval was granted (complete) or whether the approval is presently in progress (active). Thus, a substance or product that is not approved yet but about which an approval is in process and approval number is known can also have the Approval structure but must indicate a status of "active" in the Approval.statusCode. A substance or product whose approval has been withdrawn would have a statusCode of "obsolete". |
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| effectiveTime [0..1] Act (IVL<TS>) |
Design Comments: The time of the approval, or time-range for which the approval is valid. |
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| holder [0..*] (Holder) |
Design Comments: Indicates that the role player holds the approval issued by a regulatory agency. |
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| author [0..1] (Author2) |
Design Comments: The author of the Approval signifies the Territory (country or state) for which approval was granted, with optionally some detail about the approving Agency. |
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| pertinentInformation [0..*] (PertinentInformation) |
Design Comments: Specifies a policy that is relevant to the approval act. |
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| outboundRelationship [0..*] (SourceOf) |
Design Comments: A relationship linking approval or marketing authorization with related possibly more detailed approval or marketing authorizations. |
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| replacement [0..*] (ReplacementOf) |
Design Comments: An explicit representation of the relationships between approvals and renewals. This approval is at the source and the link is to the renewals, which replace this approval. |
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| Inherits associations from ProductInformation | |||||||||
| Holder |
Design Comments: Indicates that the role player holds the approval issued by a regulatory agency. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationHolder, root= "HLD"} |
Design Comments: The value provided, HLD, indicates that the associated role provides information for the holder of the authorization, i.e., the product manufacturer. [from ICSR] |
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| role [1..1] (Role) |
Design Comments: A pass-through role connecting to the product organization as the approval holder. |
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| Role |
Design Comments: A pass-through role connecting to the product organization as the approval holder. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassRoot, root= "ROL"} |
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| confidentialityCode [0..1] Role (CD) {CWE:D:Confidentiality} |
Design Comments: An indication of the level of confidentiality to be accorded to the scoping organization. B - remove from public data. |
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| playingOrganization [1..1] (E_ProductEstablishmentUniversal) | |||||||||
| Author2 |
Design Comments: The author of the Approval signifies the Territory (country or state) for which approval was granted, with optionally some detail about the approving Agency. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: Fixed to AUT (author). |
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| time [0..1] Participation (TS) |
Design Comments: The date when Approval was granted by the author. |
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| territorialAuthority [1..1] (TerritorialAuthority) |
Design Comments: The role provides a linkage to the agency that authors the approval, and to the territory over which that agency has jurisdiction. The purpose of this role is to allow either the Country code alone or the Agency or both to be specified as the author of approvals. |
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| TerritorialAuthority |
Design Comments: The role provides a linkage to the agency that authors the approval, and to the territory over which that agency has jurisdiction. The purpose of this role is to allow either the Country code alone or the Agency or both to be specified as the author of approvals. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassTerritoryOfAuthority, root= "TERR"} |
Design Comments: The value provided, TERR, indicates that information is being passed for an entity playing the role of territorial authority, within a given sphere, for another entity. [from ICSR] |
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| territory [0..1] (Territory) |
Design Comments: A politically organized body of people bonded by territory, culture, or ethnicity, having sovereignty (to a certain extend) granted by other states (enclosing or neighboring states). This includes countries (nations), provinces (e.g., one of the United States of America or a French department), counties or municipalities. Refine using, e.g., ISO country codes, FIPS-PUB state codes, etc. |
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| governingAgency [0..1] (Agency) |
Design Comments: An agency of the people of a state often assuming some authority over a certain matter. Includes government, governmental agencies, and associations. (For example the FDA approves a New Drug Application) |
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| Territory |
Design Comments: A politically organized body of people bonded by territory, culture, or ethnicity, having sovereignty (to a certain extend) granted by other states (enclosing or neighboring states). This includes countries (nations), provinces (e.g., one of the United States of America or a French department), counties or municipalities. Refine using, e.g., ISO country codes, FIPS-PUB state codes, etc. |
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| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassState, root= "STATE"} |
Design Comments: Fixed to TERR. |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: Fixed to INSTANCE. |
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| code [1..1] (M) Organization (CD) {CWE:D:TerritoryEntityType} |
Design Comments: A code to identify the country or other relevant geographic entity, e.g., European Union. |
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| name [0..1] Organization (TN) |
Design Comments: The country name, if not coded. |
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| Agency |
Design Comments: An agency of the people of a state often assuming some authority over a certain matter. Includes government, governmental agencies, and associations. (For example the FDA approves a New Drug Application) |
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| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassPublicInstitution, root= "PUB"} |
Design Comments: The value provided, PUB, indicates that public entity information is being passed. |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: The value provided, INSTANCE, indicates that the information provided refers to a specific, existing entity. |
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| id [0..1] Organization (II) |
Design Comments: A unique identifier for the organization. |
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| name [0..1] Organization (ON) |
Design Comments: A text name for the organization. E.g., the FDA for the U.S.A. |
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| addr [0..1] Organization (AD) |
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| PertinentInformation |
Design Comments: Specifies a policy that is relevant to the approval act. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| policy [1..1] (Policy) |
Design Comments: This is used to specify particular regulations or policies such as control drug schedule or local requirements to authorize use. |
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| Policy |
Design Comments: This is used to specify particular regulations or policies such as control drug schedule or local requirements to authorize use. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassPolicy, root= "POLICY"} |
Design Comments: Fixed to POLICY or specializations thereof. |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: Fixed to EVN, as it specifies particular enacted policies. |
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| code [1..1] (M) Act (CD) {CNE:D:RegulationPolicyActType} |
Design Comments: The code for the specific policy, e.g. specific controlled substance schedule. |
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| SourceOf |
Design Comments: A relationship linking approval or marketing authorization with related possibly more detailed approval or marketing authorizations. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:D:Ac_NotDefined} |
Design Comments: COMP: connects to the smaller parts of the authorization process (approvals, decisions, etc.) RPLC: connects to earlier marketing authorizations that used to apply but are now replaced by this one. APND: connects to renewals and ammendments. COVBY: connects to other authorizations based on which this authorization exists (e.g., NDA authorized generic, where the authorization is a derivative based on another company's NDA approval.) |
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| sequenceNumber [0..1] ActRelationship (INT.NONNEG) |
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| approval [1..1] (Approval) | |||||||||
| ReplacementOf |
Design Comments: An explicit representation of the relationships between approvals and renewals. This approval is at the source and the link is to the renewals, which replace this approval. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipReplaces, root= "RPLC"} |
Design Comments: The value of RPLC for "replacement of" as contained in the ActRelationshipType vocabulary domain. |
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| approval [1..1] (Approval) | |||||||||
| Management |
Design Comments: A choice of acts mostly defined for the purpose of laying out the model. |
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| choice of MarketingAct |
Design Comments: Specifies if and when the product is marketed. |
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| or MonitoringProgram |
Design Comments: Indicates a particular monitoring or reporting program to which the drug is subject. Note that monitoring programs are also included in the Policy class. The two classes exist because of different heritage from different source models joined together in the Common Product Model. |
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| Inherits associations from ProductInformation | |||||||||
| MarketingAct |
Design Comments: Specifies if and when the product is marketed. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
Design Comments: Fixed to ACT. |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: Fixed to EVN. |
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| code [0..1] Act (CD) {CWE:D:MarketingActivityActType} |
Design Comments: A coded indication of the type of marketing act. There may only be one such code in use for "marketing" in general, or potentially different codes may be used to circumscribe more specifically what marketing actions are included and how that affects the interpretation of the marketing status and date. |
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| statusCode [0..1] Act (CS) {CNE:V:ActStatus} |
Design Comments: The status of the marketing activity, i.e., product is actively marketed (active), product has been withdrawn from the market (aborted). |
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| effectiveTime [0..1] Act (IVL<TS>) |
Design Comments: Time range (start - end) in which a product was marketed. |
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| location [0..*] (Location) |
Design Comments: Links the MarketingAct with the region in which the product is being marketed. |
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| coverage [0..*] (Coverage) |
Design Comments: Relates the MarketingAct to the marketing authorization (approval) indicating that the marketing activity is covered by or is under the authority of a target marketing authorizaton. |
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| Inherits associations from ProductInformation | |||||||||
| Location |
Design Comments: Links the MarketingAct with the region in which the product is being marketed. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetLocation, root= "LOC"} |
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| role [1..1] (Role2) |
Design Comments: A pass-through Role whose player is the territory of marketing activity. |
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| Role2 |
Design Comments: A pass-through Role whose player is the territory of marketing activity. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassRoot, root= "ROL"} |
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| playingTerritory [1..1] (Territory) | |||||||||
| Coverage |
Design Comments: Relates the MarketingAct to the marketing authorization (approval) indicating that the marketing activity is covered by or is under the authority of a target marketing authorizaton. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipCoveredBy, root= "COVBY"} |
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| approval [1..1] (Approval) | |||||||||
| MonitoringProgram |
Design Comments: Indicates a particular monitoring or reporting program to which the drug is subject. Note that monitoring programs are also included in the Policy class. The two classes exist because of different heritage from different source models joined together in the Common Product Model. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassMonitoringProgram, root= "MPROT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [1..1] (M) Act (CD) {CWE:D:ActCode} |
Design Comments: A coded indication of the type of monitoring program. |
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| title [0..1] Act (ST) |
Design Comments: The name of the monitoring program. |
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| custodian [0..1] (Custodian) |
Design Comments: The organization that runs the monitoring program. |
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| Inherits associations from ProductInformation | |||||||||
| Custodian |
Design Comments: The organization that runs the monitoring program. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationCustodian, root= "CST"} |
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| assignedEntity2 [1..1] (R_ProductRelatedAssignedEntityUniversal) | |||||||||
| Characteristics | |||||||||
| choice of Characteristic |
Design Comments: A code-value pair specifying descriptive properties of the medicine, such as color, shape, imprints, etc. The code has a data type of CE and the value has a data type of ANY, which allows codes or numeric values to be specified. This includes physical characteristics of the product, e.g., size, weight, as well as more abstract items such as whether the product is labeled for single use. A statement about a particular ingredient not being included within a product is also handled as a product characteristic. |
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| or ObservationGoal |
Design Comments: A desired characteristic of the product when it is reconstituted, i.e., a goal for the observation to be made for the reconstituted product. For example, allows stating the pH or osmolality of a powder for reconstitution. The "QS" null flavor is used with this goal to indicate the variable amount adjustable to meet the goal. |
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| or A_SubstanceSpecificationUniversal | |||||||||
| Inherits associations from ProductInformation | |||||||||
| Characteristic |
Design Comments: A code-value pair specifying descriptive properties of the medicine, such as color, shape, imprints, etc. The code has a data type of CE and the value has a data type of ANY, which allows codes or numeric values to be specified. This includes physical characteristics of the product, e.g., size, weight, as well as more abstract items such as whether the product is labeled for single use. A statement about a particular ingredient not being included within a product is also handled as a product characteristic. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: The value provided, OBS, indicates that observation information is being passed. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| code [1..1] Observation (CD) {CWE:D:ObservationType} |
Design Comments: A code specifying which characteristic of the medicine is being described. The vocabulary domain is MedicationObservationType (a CWE domain which can be extended as necessary). For example, some values that are contained in the SPL Label Data value set within the MedicationObservationType vocabulary domain are listed below: * SPLIMPRINTCD - imprint code - Identifying marks on product * SPLSIZE - size - Description of size of the product as called for in regulations * SPLSHAPE - shape - Description of shape of the product as called for in regulations * SPLCOLOR - color - Description of color of the product as called for in regulations * SPLCOATING - coating - Description of the coating of the product as called for in regulations * SPLSCORING - scoring - Description of scoring of the product as called for in regulations * SPLSYMBOL - logo - Description of the logo on the product as called for in regulations [from SPL] |
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| text [0..1] Observation (ED) |
Design Comments: A text field that allows entry of free text description of the characteristics. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The value of the characteristic, e.g., a code for the specific shape or color, or a physical quantity specification for the size. |
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| methodCode [0..*] Observation (DSET<CD>) {CWE:D:ObservationMethod} |
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| analyte [0..1] (Analyte) | |||||||||
| participation [0..*] (Interactor) | |||||||||
| Inherits associations from ProductInformation | |||||||||
| Analyte | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAnalyte, root= "ALY"} |
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| substanceRole [1..1] (R_SubstanceUniversal) | |||||||||
| Interactor | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ReactionParticipant} |
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| functionCode [0..1] Participation (CD) {CWE:D:MolecularInteractionFunction} |
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| quantity [0..1] Participation (PQ) |
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| substanceRole [1..1] (R_SubstanceUniversal) | |||||||||
| ObservationGoal |
Design Comments: A desired characteristic of the product when it is reconstituted, i.e., a goal for the observation to be made for the reconstituted product. For example, allows stating the pH or osmolality of a powder for reconstitution. The "QS" null flavor is used with this goal to indicate the variable amount adjustable to meet the goal. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodGoal, root= "GOL"} |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
Design Comments: A coded indication of the property which the goal specifies (e.g., pH). |
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| text [0..1] Observation (ED) |
Design Comments: A text description of the goal. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The constraint given for the observation goal, i.e., if an actual observation falls within that constraint (or meets the measurement within some reasonable margin of error) then the goal is considered met. |
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| Inherits associations from ProductInformation | |||||||||
| Storage |
Design Comments: Specifies a suggested manner of storage of the product and the time the product is good to use if stored in this manner (shelf life). The storage conditions (temperature, humidity, etc.) are specified using one storage condition control variables. |
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| classCode [1..1] (M) Act (CS) {CNE:} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| code [0..1] Act (CD) {CWE:D:ActStorageType} |
Design Comments: An optional code specifying a storage or a more specific manner of storage. Note this code should likely not attempt to precoordinate storage conditions which are to be described separately. |
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| text [0..1] Act (ST) |
Design Comments: Text description of the storage instructions. To be used sparingly. |
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| effectiveTime [0..1] Act (IVL.WIDTH<TS>) |
Design Comments: The shelf life time under the specified storage conditions. |
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| controlVariable [0..*] (ControlVariable) |
Design Comments: Links a manner of storage (with shelf life) to one of its set of environmental conditions defining this manner of storage. |
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| Inherits associations from ProductInformation | |||||||||
| ControlVariable |
Design Comments: Links a manner of storage (with shelf life) to one of its set of environmental conditions defining this manner of storage. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
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| storageCondition [1..1] (StorageCondition) |
Design Comments: Specifies one environmental condition of the storage, such as temperature, humidity, atmospheric pressure as a quantity range. It may also specify orientation, protection from light, etc. in coded form. |
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| StorageCondition |
Design Comments: Specifies one environmental condition of the storage, such as temperature, humidity, atmospheric pressure as a quantity range. It may also specify orientation, protection from light, etc. in coded form. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventCriterion, root= "EVN.CRT"} |
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| code [0..1] Observation (CD) {CWE:D:ObservationType} |
Design Comments: The property of the storage condition, such as temperature, humidiy, atmospheric pressure, orientation, protection from light, etc. |
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| isCriterionInd [0..1] Observation (BL){fixed value= "true"} |
Design Comments: Fixed value (true) indicating that this is a criterion and not an event that actually took place. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The value range of the storage condition, typically an IVL<PQ> for environmental conditions, or coded for orientation, protection from light, etc. |
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