Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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: CMCeCTDDocument32S3 - Mappings

Page standards status: Trial-use | Maturity Level: 2

Mappings for the cmc-ectd-document-32s3 resource profile.

#### Mappings to Structures in this Implementation Guide

No Mappings Found

#### Mappings to other Structures

No Mappings Found

#### Other Mappings

Name | FiveWs Pattern Mapping | HL7 V2 Mapping | RIM Mapping | CDA (R2)
--- | --- | --- | --- | ---
Bundle | infrastructure.structure | N/A | Entity. Role or Act N/A | ClinicalDocument if bundle.type = document
id |  |  |  |
meta |  |  |  |
implicitRules |  |  |  |
language |  |  |  |
identifier | FiveWs.identifier |  |  | ClinicalDocument.id
type | FiveWs.class |  |  |
timestamp | FiveWs.init |  |  | ClinicalDocument.effectiveTime
total |  |  |  |
link |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
relation |  |  |  |
url |  |  |  |
Slices for entry |  |  |  |
entry:All Slices |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource |  |  |  |
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
entry:Composition |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource | infrastructure.documents |  | Entity Role or Act Document[classCode="DOC" and moodCode="EVN" and isNormalAct()] | ClinicalDocument
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
entry:Characterisation |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource | administrative.medication |  | Entity Role or Act |
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
entry:Organization |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource | administrative.group | (also see master files messages) | Entity Role or Act Organization(classCode=ORG determinerCode=INST) |
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
entry:Impurity |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource | administrative.medication |  | Entity Role or Act |
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
entry:GraphicsFile |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource | infrastructure.documents |  | Entity Role or Act Document[classCode="DOC" and moodCode="EVN"] | when describing a CDA
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
entry:StructureFile |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
link |  |  |  |
fullUrl |  |  |  |
resource | infrastructure.documents |  | Entity Role or Act Document[classCode="DOC" and moodCode="EVN"] | when describing a CDA
search |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
mode |  |  |  |
score |  |  |  |
request |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
method |  |  |  |
url |  |  |  |
ifNoneMatch |  |  |  |
ifModifiedSince |  |  |  |
ifMatch |  |  |  |
ifNoneExist |  |  |  |
response |  |  |  |
id |  |  | n/a |
extension |  |  | n/a |
modifierExtension |  |  | N/A |
status |  |  |  |
location |  |  |  |
etag |  |  |  |
lastModified |  |  |  |
outcome |  |  |  |
signature |  |  |  |
issues |  |  |  |
Documentation for this format