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| − | <div class="messagebox cleanup metadata">
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| − | <div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>
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| − | <div style="background:#F0F0F0">
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| − | This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
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| − | </div>
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| − | </div>
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| − | [[Category:FHIR Resource Proposal]]
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| − | [[Category:Pending FHIR Resource Proposal]]
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| − | <!-- For additional guidance on considerations for resource creation, refer to [[FHIR Resource Considerations]] -->
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| − | =SubstanceSpecification=
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| − | <!-- Resource names should meet the following characteristics:
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| − | * Lower camel case
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| − | * U.S. English
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| − | * Domain-friendly
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| − | * Short
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| − | * Clear
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| − | * Unique
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| − | * Avoid non-universal abbreviations (e.g. URL would be ok)
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| − | * Be expressed as a noun
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| − | * Be consistent with other similar resources
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| − | -->
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| − | ==Owning work group name==
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| − | <!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
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| − | [[BR&R]]
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| − | ==Committee Approval Date:==
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| − | <i>13th September 2017</i>
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| − | ==Contributing or Reviewing Work Groups==
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| − | <!-- Additional work groups that may have an interest in contributing to, or reviewing the content of the resource (optional) -->
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| − | * Pharmacy
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| − | * O&O
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| − | ==FHIR Resource Development Project Insight ID==
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| − | 1338
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| − | <!-- Please specify the id of your work group’s PSS for doing FHIR work. (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
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| − |
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| − | ==Scope of coverage==
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| − | To support the content of the revised ISO 11238 IDMP Substance standard and its ISO/TS 19844 Technical Specification, and other domain areas with similar requirements (detailed definition of substances, to molecular level, including manufacturing processes and ingredients).
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| − | ==RIM scope==
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| − | Similar in scope to the substance parts of CPM. Entity: Material (EntityClass="MAT")
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| − | ==Resource appropriateness==
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| − | There is an upcoming requirement to support the standardised exchange of detailed definitional Substance data, as covered by the ISO 11238 specification.
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| − | This resource does not intend to clash with the existing Substance FHIR resource, but complements with an extra level of detail. It is seen as a sibling rather than a parent or a superclass to be profiled.
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| − | It is intended to add an extra level of substance specification detail, such as is typically used by regulators, and only indirectly used during normal medication related work flows (e.g. for lookups of unfamiliar substances).
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| − | Manufacturers submit this data to regulators, when substances are created or the parameters change (ingredient manufacturer, process etc).
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| − | Regulators exchange this information between each other, to synchronize substance catalogs.
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| − | ==Expected implementations==
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| − | FDA (already implemented a proprietary message solution for 11238 substances).
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| − | EMA
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| − | ==Content sources==
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| − | Basis for the resource is the information in ISO 11238 Substances standard. Actual data exists in the FDA GSRS implementation of 11238.
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| − | ==Example Scenarios==
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| − | Substance definitions for the various categories (Chemical, Polymer, Protein etc). Use of "Specified Substance" area of 11238 to add extra information around manufacturing process etc.
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| − | ==Resource Relationships==
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| − | Reference to Organization, for manufacturer.
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| − | Expected to be a reference from Substance to SubstanceSpecification, to be able to point to a more detailed definition
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| − | ==Timelines==
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| − | Early draft by December 2017 comment-only ballot.
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| − | ==gForge Users==
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| − | riksmithies (already has commit permission)
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| − | ==When Resource Proposal Is Complete==
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| − | '''When you have completed your proposal, please send an email to [mailto:FMGcontact@HL7.org FMGcontact@HL7.org]'''
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| − |
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| − | ==FMG Notes==
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