Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: CMCeCTDDocument32S10 - Mappings

Active as of 2024-04-04

Mappings for the cmc-ectd-document-32s10 resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

CMCeCTDDocument32S10
Bundleinfrastructure.structure
   identifierFiveWs.identifier
   typeFiveWs.class
   timestampFiveWs.init

Mappings for HL7 V2 Mapping (http://hl7.org/v2)

CMCeCTDDocument32S10
BundleN/A
   identifier
      useN/A
      typeCX.5
      systemCX.4 / EI-2-4
      valueCX.1 / EI.1
      periodCX.7 + CX.8
      assignerCX.4 / (CX.4,CX.9,CX.10)

Mappings for RIM Mapping (http://hl7.org/v3)

CMCeCTDDocument32S10
BundleEntity. Role, or Act,N/A
   meta
      idn/a
      extensionn/a
   identifier
      idn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   link
      idn/a
      extensionn/a
      modifierExtensionN/A
   entry
      idn/a
      extensionn/a
      modifierExtensionN/A
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A

Mappings for CDA (R2) (http://hl7.org/v3/cda)

CMCeCTDDocument32S10
BundleClinicalDocument, if bundle.type = document
   identifierClinicalDocument.id
   timestampClinicalDocument.effectiveTime