diff --git a/input-cache/txcache/iso3166.cache b/input-cache/txcache/iso3166.cache index f4e73d12..6e69dad3 100644 --- a/input-cache/txcache/iso3166.cache +++ b/input-cache/txcache/iso3166.cache @@ -10703,4 +10703,3 @@ e: { "error" : "" } ------------------------------------------------------------------------------------- - diff --git a/input/fsh/Terminologies.fsh b/input/fsh/Terminologies.fsh index 92986596..f993e44e 100644 --- a/input/fsh/Terminologies.fsh +++ b/input/fsh/Terminologies.fsh @@ -58,6 +58,7 @@ Description: "The type of the product name. Often the proprietary name is unknow * $NCIT#C71898 "Proprietary Name" * $NCIT#C96971 "Nonproprietary Name" + ValueSet: PqcmcTestCategoryTerminology Id: pqcmc-test-category-terminology Title: "Test Category Terminology" @@ -361,6 +362,7 @@ Description: "Substance classes" //* $NCIT#QualStd "Quality Standard" //* $NCIT#Sterile "Sterile Product Indicator" + ValueSet: CmcCompSectionTypesVS Id: cmc-comp-section-types-vs Title: "eCTD sections Terminology" diff --git a/input/fsh/examples/Example1Drug.fsh b/input/fsh/examples/Example1Drug.fsh index eccdb85f..ad63da4c 100644 --- a/input/fsh/examples/Example1Drug.fsh +++ b/input/fsh/examples/Example1Drug.fsh @@ -310,37 +310,35 @@ Usage: #inline * title = "eCTD Product Description and Composition for Example1Drug" * section[ProductDescription].title = "Product Description for Example1Drug" * section[ProductDescription].entry = Reference(urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc) -* section[ProductDescription].code.text = "Product Description" -* section[ProductComposition].title = "Product Composition for Example1Drug" -* section[ProductComposition].entry = Reference(urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149) -* section[ProductComposition].code.text = "Product Composition" +* section[ProductDescription].code = $SectionTypes#32P11 "Product Description" * section[ContainerClosure].title = "Container Closure Description for Example1Drug" * section[ContainerClosure].entry = Reference(urn:uuid:77ad6922-9c59-43d1-93cb-29d063cc2e8c) -* section[ContainerClosure].code.text = "Product Container Closure Description" +* section[ContainerClosure].code = $SectionTypes#32P13 "Product Container Closure Description" +* section[ProductComposition].title = "Product Composition for Example1Drug" +* section[ProductComposition].entry = Reference(urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149) +* section[ProductComposition].code = $SectionTypes#32P12 "Product Composition" Instance: bd0f0a7a-27ea-4884-801d-bd0546e80888 InstanceOf: CMCeCTDDocument32P10 Title: "CMCeCTDDocument32P10 bundle" Description: "A bundle for 3.2.P.1.0" -Usage: #example +Usage: #example * identifier.system = $IDsys * identifier.value = "urn:uuid:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f" * timestamp = 2023-12-09T07:12:23.538Z * entry[0].resource = 5dfbbf17-05c0-441d-af66-7a66072f4ae4 * entry[=].fullUrl = "urn:uuid:5dfbbf17-05c0-441d-af66-7a66072f4ae4" -* entry[+].resource = a8316fc9-8ca8-4115-81c1-9f8f84c99149 -* entry[=].fullUrl = "urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149" -* entry[+].resource = 5772a6f2-cde1-4903-bfcf-1639340205cc -* entry[=].fullUrl = "urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc" * entry[+].resource = 77ad6922-9c59-43d1-93cb-29d063cc2e8c * entry[=].fullUrl = "urn:uuid:77ad6922-9c59-43d1-93cb-29d063cc2e8c" -* entry[+].resource = 4f3e9af1-306b-4fad-bf04-7881400b266a -* entry[=].fullUrl = "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" -* entry[+].resource = 7f10a35e-228d-42db-8918-6ccada78454d -* entry[=].fullUrl = "urn:uuid:7f10a35e-228d-42db-8918-6ccada78454d" +* entry[+].resource = 5772a6f2-cde1-4903-bfcf-1639340205cc +* entry[=].fullUrl = "urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc" +* entry[+].resource = a8316fc9-8ca8-4115-81c1-9f8f84c99149 +* entry[=].fullUrl = "urn:uuid:a8316fc9-8ca8-4115-81c1-9f8f84c99149" * entry[+].resource = fc09842a-8f71-48f2-9f9f-ff2441b2eb6f * entry[=].fullUrl = "urn:uuid:fc09842a-8f71-48f2-9f9f-ff2441b2eb6f" +* entry[+].resource = 7f10a35e-228d-42db-8918-6ccada78454d +* entry[=].fullUrl = "urn:uuid:7f10a35e-228d-42db-8918-6ccada78454d" * entry[+].resource = d01421cc-6488-468b-a676-d3e7281875e2 * entry[=].fullUrl = "urn:uuid:d01421cc-6488-468b-a676-d3e7281875e2" * entry[+].resource = 3791c4ce-2b43-4d7b-b195-0e5f88f28dab @@ -353,6 +351,8 @@ Usage: #example * entry[=].fullUrl = "urn:uuid:393a14e7-3edc-4373-bbe5-9e569d504a1c" * entry[+].resource = 496f83ad-2365-4b12-8672-a349d99f7d67 * entry[=].fullUrl = "urn:uuid:496f83ad-2365-4b12-8672-a349d99f7d67" +* entry[+].resource = 4f3e9af1-306b-4fad-bf04-7881400b266a +* entry[=].fullUrl = "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" * entry[+].resource = 8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9 * entry[=].fullUrl = "urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9" * entry[+].resource = 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 diff --git a/input/fsh/examples/ExampleSpecification.fsh b/input/fsh/examples/ExampleSpecification.fsh index a073b540..f018e237 100644 --- a/input/fsh/examples/ExampleSpecification.fsh +++ b/input/fsh/examples/ExampleSpecification.fsh @@ -2,8 +2,7 @@ Instance: 89676a69-1fe7-422c-ab00-92abe4ef6ea9 InstanceOf: DrugProductHandle Title: "drug product for specification" Description: "Includes the identifier of the drug product" -Usage: #inline - + Usage: #inline * identifier.value = "Example2BeadDrug" * combinedPharmaceuticalDoseForm = $NCIT#C25158 "CAPSULE" diff --git a/input/fsh/examples/ExampleSpecification2.fsh b/input/fsh/examples/ExampleSpecification2.fsh index b372a4cf..706abfe8 100644 --- a/input/fsh/examples/ExampleSpecification2.fsh +++ b/input/fsh/examples/ExampleSpecification2.fsh @@ -2,7 +2,7 @@ Instance: d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 InstanceOf: CodedOrganization Title: "Example of a Supplier Organization" Description: "This example if for a Supplier Organization" -Usage: #inline + Usage: #inline * identifier[DUNSNumber].type = $NCIT#C134003 "DUNS" * identifier[DUNSNumber].value = "173265332" * identifier[DUNSNumber].type = $NCIT#C134003 "DUNS" diff --git a/input/fsh/examples/levoThyroxine.fsh b/input/fsh/examples/levoThyroxine.fsh index 1af71d62..c17296aa 100644 --- a/input/fsh/examples/levoThyroxine.fsh +++ b/input/fsh/examples/levoThyroxine.fsh @@ -2,7 +2,7 @@ Instance: b69435a0-45c6-4d44-9fde-b354e17408d7 InstanceOf: CodedOrganization Title: "Sponsor of API" Description: "CodedOrganization - Large Life" -Usage: #inline + Usage: #inline * name = "Large Life" * contact.address @@ -21,7 +21,7 @@ Instance: e165f057-5eed-4e64-8328-4438fc88fb1b InstanceOf: CodedOrganization Title: "Drug Manufacturing Site - Vandechemie" Description: "Example of Manufacturing site using the CodedOrganization profile - Vandechemie" -Usage: #inline + Usage: #inline * name = "Vandechemie" * contact.address * type = #postal @@ -38,7 +38,7 @@ Instance: e875ef93-a730-4c44-bead-53663ae7f501 InstanceOf: CodedOrganization Title: "East-West Manufacturing" Description: "Manufacture of Chemicals" -Usage: #inline + Usage: #inline * identifier[DUNSNumber].value = "143265222" * identifier[DUNSNumber].type = $NCIT#C134003 "DUNS" @@ -61,7 +61,7 @@ Instance: 0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3 InstanceOf: GraphicReference Title: "Base64 Document Reference - Monosodium_D-thyroxine_hydrate.png" Description: "Monosodium D-thyroxine hydrate.png" -Usage: #inline + Usage: #inline * content.attachment.contentType = urn:ietf:bcp:13#image/png * content.attachment.data = 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* content.attachment.title = "Monosodium_D-thyroxine_hydrate.png" @@ -86,7 +86,7 @@ Instance: d94ad7ac-b935-432f-bc68-312b6b8dcca7 InstanceOf: GraphicReference Title: "Base64 Document Reference - Levothyroid.png" Description: "Base 64 Document - png file" -Usage: #inline + Usage: #inline * content.attachment.contentType = urn:ietf:bcp:13#image/png * content.attachment.data = 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* content.attachment.title = "Levothyroid.png" @@ -95,7 +95,7 @@ Instance: 22bd989e-8056-494f-9bc1-195d13428179 InstanceOf: StructureReference Title: "Base64 Document Reference - L-thyroxine-3D-structure-CT1000583834.sdf" Description: "An attached SDfile. The ASCII file content is attached in base64." -Usage: #inline + Usage: #inline * content.attachment.contentType = urn:ietf:bcp:13#application/x-mdl-sdfile * content.attachment.data = """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""" * content.attachment.title = "L-thyroxine-3D-structure-CT1000583834.sdf" @@ -144,7 +144,7 @@ Instance: 30536c0e-456c-4f90-9f02-da7be1d289e9 InstanceOf: CMCeCTDDocument32S10 Title: "Bundle for 3.2.S.1" Description: "Bundle containng nomenclature and molecular structure" -Usage: #example +Usage: #example * identifier.system = $IDsys * identifier.value = "urn:uuid:1bf43677-1c61-41dd-93c2-8ec7f327d0f1" * timestamp = 2023-12-15T22:19:47.022Z diff --git a/input/fsh/examples/materials1.fsh b/input/fsh/examples/materials1.fsh index 2456d019..2ce8730c 100644 --- a/input/fsh/examples/materials1.fsh +++ b/input/fsh/examples/materials1.fsh @@ -2,7 +2,7 @@ Instance: 49438799-e286-432c-b8d8-68ac77e7f519 InstanceOf: CodedOrganization Title: "CodedOrganization J. Jones Research" Description: "Example of a Sponsor type of Organization" -Usage: #inline + Usage: #inline * identifier[DUNSNumber].type = $NCIT#C134003 "DUNS" * identifier[DUNSNumber].value = "143265625" * identifier[DUNSNumber].system = $DUNS @@ -20,7 +20,7 @@ Instance: 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 InstanceOf: CodedOrganization Title: "Manufacturing Site (J. Jones Research)" Description: "Manufacturing site instance of an Organization Example. There will be a type code in future" -Usage: #inline + Usage: #inline * identifier[DUNSNumber].type = $NCIT#C134003 "DUNS" * identifier[DUNSNumber].value = "783452221" * identifier[DUNSNumber].system = $DUNS @@ -41,7 +41,7 @@ Instance: e99bddfa-c1b5-435b-bbe8-24816b4e23e5 InstanceOf: CodedOrganization Title: "Vidinaid" Description: "Manufacturing site (Vidinaid) instance with second address line" -Usage: #inline + Usage: #inline * identifier[DUNSNumber].value = "143265222" * identifier[DUNSNumber].type = $NCIT#C134003 "DUNS" * identifier[DUNSNumber].system = $DUNS diff --git a/input/ignoreWarnings.txt b/input/ignoreWarnings.txt index 947a17c0..1270137e 100644 --- a/input/ignoreWarnings.txt +++ b/input/ignoreWarnings.txt @@ -84,7 +84,6 @@ Unknown System 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context- Reference to deprecated ValueSet http://hl7.org/fhir/ValueSet/jurisdiction|5.0.0 %binds to the value set 'http://hl7.org/fhir/ValueSet/jurisdiction' which is experimental, but this structure is not labeled as experimental - # 07 - They are inline examples so that they just show in the bundles. Comes from having to restrict references to be bundled only. The usage is set to inline because the publisher does not support remote reference defined in the bundle. INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure'): The Implementation Guide contains no explicitly linked examples for this profile INFORMATION: StructureDefinition.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization'): The Implementation Guide contains no explicitly linked examples for this profile diff --git a/input/images/NarrativeTransform.zip b/input/images/NarrativeTransform.zip index 126587c4..6110461c 100644 Binary files a/input/images/NarrativeTransform.zip and b/input/images/NarrativeTransform.zip differ diff --git a/input/pagecontent/index.md b/input/pagecontent/index.md index 7635bef6..7aa26a15 100644 --- a/input/pagecontent/index.md +++ b/input/pagecontent/index.md @@ -58,7 +58,7 @@ There is another project in HL7 BR&R that covers the domain of Pharmaceutical Qu The first version of the PQ/CMC IG is bound to FHIR R5. It consists of four FHIR bundle profiles that are scoped to the FDA PQ/CMC Phase 1, Stage 1 requirements and are aligned with sections of Module 3 of ICH CTD as indicated by the profile title. -The FHIR resources leveraged in all of Phase 1 are listed below and represented in Figure 3 below. The four Stage 1 FHIR bundle profiles are composed from nine FHIR Resources. These nine FHIR resources are identified in the list below with an "*" asterisk after the resource name. +The FHIR resources leveraged in all of Phase 1 are listed below and represented in Figure 3 below. The four Stage 1 FHIR bundle profiles are composed from eight FHIR Resources. These eight FHIR resources are identified in the list below with an "*" asterisk after the resource name. Note: The first 2 FHIR resources – Bundle and Composition are organizational profiles used to package the content/domain resources.