| publicId |
6390920 |
| version |
1 |
| longName |
Lot Number |
| shortName |
EXLOT |
| definition |
Lot Number of the EXTRT product. |
| context |
NCI Standards |
| origin |
CDISC:Clinical Data Interchange Standards Consortium |
| workflowStatus |
RELEASED |
| registrationStatus |
Standard |
| latestVersionIndicator |
Yes |
| beginDate |
2018-08-10 |
| endDate |
|
| changeDescription |
8-10-18 Created as part of the CDISC mapping task; tt. |
| administrativeNotes |
02.13.23_Set Reg Status to Standard for all CDISC Aligned content_ghd |
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
TAYLORT |
| dateCreated |
2018-08-10 |
| modifiedBy |
MMADDINENI |
| dateModified |
2024-03-04 |
| DataElementConcept |
| publicId |
6384861 |
| version |
1 |
| longName |
Exposure Domain Exposure Lot Number |
| shortName |
6384837v1.0:6384859v1.0 |
| definition |
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to exposure._The numerical identifier of the medication exposure lot. |
| context |
NCI Standards |
| origin |
CDISC:Clinical Data Interchange Standards Consortium |
| workflowStatus |
RELEASED |
| registrationStatus |
Qualified |
| latestVersionIndicator |
Yes |
| beginDate |
2018-08-07 |
| endDate |
|
| changeDescription |
8-7-18 Created as part of the CDISC mapping task; tt. |
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
TAYLORT |
| dateCreated |
2018-08-07 |
| modifiedBy |
MMADDINENI |
| dateModified |
2024-03-04 |
| ObjectClass |
| publicId |
6384837 |
| version |
1 |
| longName |
Exposure Domain |
| shortName |
C49587 |
| definition |
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to exposure. |
| context |
NCIP |
| origin |
NCI Thesaurus |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| latestVersionIndicator |
Yes |
| beginDate |
2018-08-07 |
| endDate |
|
| changeDescription |
|
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
TAYLORT |
| dateCreated |
2018-08-07 |
| modifiedBy |
ONEDATA |
| dateModified |
2018-08-07 |
| Concepts |
| longName |
Exposure Domain |
| conceptCode |
C49587 |
| definition |
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to exposure. |
| evsSource |
NCI_CONCEPT_CODE |
| primaryIndicator |
Yes |
| displayOrder |
0 |
|
|
|
| Property |
| publicId |
6384859 |
| version |
1 |
| longName |
Exposure Lot Number |
| shortName |
C83099 |
| definition |
The numerical identifier of the medication exposure lot. |
| context |
NCIP |
| origin |
NCI Thesaurus |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| latestVersionIndicator |
Yes |
| beginDate |
2018-08-07 |
| endDate |
|
| changeDescription |
|
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
TAYLORT |
| dateCreated |
2018-08-07 |
| modifiedBy |
ONEDATA |
| dateModified |
2018-08-07 |
| Concepts |
| longName |
Exposure Lot Number |
| conceptCode |
C83099 |
| definition |
The numerical identifier of the medication exposure lot. |
| evsSource |
NCI_CONCEPT_CODE |
| primaryIndicator |
Yes |
| displayOrder |
0 |
|
|
|
| ConceptualDomain |
| publicId |
2435019 |
| version |
1 |
| longName |
Conceptual Entity |
| shortName |
C20181 |
| definition |
An organizational header for concepts representing mostly abstract entities. |
| context |
NCIP |
| origin |
NCI Thesaurus |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| latestVersionIndicator |
Yes |
| beginDate |
2005-12-06 |
| endDate |
|
| changeDescription |
|
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
CURTIST |
| dateCreated |
2005-12-06 |
| modifiedBy |
SBR |
| dateModified |
2006-12-20 |
|
|
| ValueDomain |
| publicId |
6353492 |
| version |
1 |
| longName |
CDISC Variable Terminology Identifier |
| shortName |
CDISCID |
| definition |
The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) variables._One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. |
| context |
NCI Standards |
| type |
Non-enumerated |
| dataType |
CHARACTER |
| minLength |
|
| maxLength |
40 |
| minValue |
|
| maxValue |
|
| decimalPlace |
|
| origin |
CDISC:Clinical Data Interchange Standards Consortium |
| workflowStatus |
RELEASED |
| registrationStatus |
Standard |
| latestVersionIndicator |
Yes |
| beginDate |
2018-07-12 |
| endDate |
|
| changeDescription |
Elevated to Standard per governance approval by RA. 2021-6-9 ak 1/4/19 tmt released/usage. Created as part of CDISC mapping task. 7.12.18 mc |
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
COOPERM |
| dateCreated |
2018-07-12 |
| modifiedBy |
TYRRELLM |
| dateModified |
2026-09-02 |
| ConceptualDomain |
| publicId |
2435019 |
| version |
1 |
| longName |
Conceptual Entity |
| shortName |
C20181 |
| definition |
An organizational header for concepts representing mostly abstract entities. |
| context |
NCIP |
| origin |
NCI Thesaurus |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| latestVersionIndicator |
Yes |
| beginDate |
2005-12-06 |
| endDate |
|
| changeDescription |
|
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
CURTIST |
| dateCreated |
2005-12-06 |
| modifiedBy |
SBR |
| dateModified |
2006-12-20 |
|
| RepresentationTerm |
| publicId |
6396665 |
| version |
1 |
| longName |
CDISC Variable Terminology Identifier |
| shortName |
C83187:C25364 |
| definition |
The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) variables.:One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. |
| context |
NCIP |
| origin |
|
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| latestVersionIndicator |
Yes |
| beginDate |
2018-08-13 |
| endDate |
|
| changeDescription |
|
| administrativeNotes |
|
| unresolvedIssues |
|
| deletedIndicator |
No |
| createdBy |
TAYLORT |
| dateCreated |
2018-08-13 |
| modifiedBy |
ONEDATA |
| dateModified |
2018-08-13 |
| Concepts |
| longName |
CDISC Variable Terminology |
| conceptCode |
C83187 |
| definition |
The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) variables. |
| evsSource |
NCI_CONCEPT_CODE |
| primaryIndicator |
No |
| displayOrder |
1 |
|
| longName |
Identifier |
| conceptCode |
C25364 |
| definition |
One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. |
| evsSource |
NCI_CONCEPT_CODE |
| primaryIndicator |
Yes |
| displayOrder |
0 |
|
|
|
|
| ClassificationSchemes |
| publicId |
6338162 |
| version |
1 |
| longName |
CDISC (NCI Implementation) |
| context |
NCI Standards |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| ClassificationSchemeItems |
| publicId |
6338163 |
| version |
1 |
| longName |
CDASH |
| context |
NCI Standards |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
|
| publicId |
7329797 |
| version |
1 |
| longName |
Exposure (EX) Domain |
| context |
NCI Standards |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
|
| publicId |
7329810 |
| version |
1 |
| longName |
Recommended/Conditional Core |
| context |
NCI Standards |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
|
|
|
| publicId |
6685474 |
| version |
1 |
| longName |
Artificial Neural Network Algorithm for BRIDG Mapping |
| context |
NCIP |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
| ClassificationSchemeItems |
| publicId |
6685479 |
| version |
1 |
| longName |
Testing Set – Semantically Different |
| context |
NCIP |
| workflowStatus |
RELEASED |
| registrationStatus |
Application |
|
|
|
|
| AlternateNames |
| name |
EX.EXLOT |
| type |
Map:CDASHv1.1 |
| context |
NCIP |
|
|
| ReferenceDocuments |
| documentName |
Case Report Form Completion Instructions |
| documentText |
Record the lot number that appears on the container holding the study treatment. |
| documentType |
CDISC CRF Instruction |
| url |
|
| context |
NCI Standards |
|
| documentName |
EXLOT |
| documentText |
Maps directly to the SDTMIG variable. |
| documentType |
CDASH to SDTM Mapping |
| url |
|
| context |
NCI Standards |
|
| documentName |
CDASH Implementation Notes |
| documentText |
The Lot Number identifies the manufacturing batch of the study treatment. In open label studies, the reference number on the study treatment container may represent an actual Lot Number and is submitted using EXLOT. This variable may be populated during the process of creating the SDTM submission datasets. Do not collect other identification variables in this field. |
| documentType |
CDASH Implementation Note |
| url |
|
| context |
NCI Standards |
|
| documentName |
Permissible |
| documentText |
Permissible |
| documentType |
SDTM Core |
| url |
|
| context |
NCI Standards |
|
| documentName |
What was the lot number of th |
| documentText |
What was the lot number of the study treatment used? |
| documentType |
Preferred Question Text |
| url |
|
| context |
NCI Standards |
|
| documentName |
CDASH Prompt |
| documentText |
Lot Number |
| documentType |
Alternate Question Text |
| url |
|
| context |
NCI Standards |
|
| documentName |
CDISC Aligned NCI Standard Equivalent CDE |
| documentText |
This data element is to be used for CDISC aligned data collection in place of CDE 62592 from the original NCI Standard CRF Template. |
| documentType |
CDISC Note |
| url |
|
| context |
NCI Standards |
|
| documentName |
CDISC Aligned NCI Standard Template Text |
| documentText |
Study Treatment Identification Number |
| documentType |
Alternate Question Text |
| url |
|
| context |
NCI Standards |
|
| documentName |
DCP- CRF Text 1 |
| documentText |
Lot # |
| documentType |
Alternate Question Text |
| url |
|
| context |
DCP |
|
|