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Laboratory Data Model
Base Model Version 1.0.1
Final XML Schema Version 1.0.1
Microbiology Extension Review Version
Reference Range Model Review Version
The CDISC LAB
Base Model Version 1.0.1 is being released to
industry for implementation. This update incorporates
changes to model specifications to address minor
bugs and to harmonize with CDISC's Operational
Data Model and Submissions Data Standards Model.
As of April 2004, the CDISC LAB Team is releasing
the final XML schema representation of the model
for implementation. In addition, sample datasets
are provided to further illustrate the use of
the Lab Model. The Microbiology Extension is
under review by the LAB team. Comments on the
draft microbiology and ECG extensions as well
as any comments on LAB Model Version 1.0.1 (Base
and XML Schema) can be submitted via the CDISC
Discussion Forum. The Lab Model files are described
below.
The following
file documents the contents of this release:
| LabModelReleaseNotes.pdf
|
Description of this release |
| LabModel.zip |
Zip file of all files in this release |
The
following files document the Base model Version
1.0.1 and are being posted for implementation:
Lab1-0-1-Specification.pdf
|
The Lab Model V1.0.1 specification
in pdf format |
| Lab1-0-2-BaseDataFields.xls |
The Lab Base Model V1.0.2 data fields
in Excel spreadsheet format |
| Lab1-0-1-ReferenceRanges.xls |
The Lab Model V1.0.1 reference ranges
in Excel spreadsheet format |
| LabReviewBaseSampleData.dat |
Base model sample data for use with SAS
and ASCII |
The following files document the XML schema
implementation of the Base model and are posted
as final versions for implementation:
Lab1-0-1-BaseSchema.xsd
|
Base model XML schema |
| Lab1-0-1-Base.doc |
Text outline for the base model XML schema |
| Lab1-0-1-BaseSampleData.xml |
Base model sample data in XML format |
The following files document the Microbiology
Extension and are posted as drafts for comment:
LabReviewMicroDataFields.xls
|
The Lab Microbiology extension
data fields in Excel spreadsheet format |
| LabReviewMicroSchema.xsd |
Microbiology extension XML schema |
LabReviewMicro.doc
|
Text outline for the microbiology extension
XML schema |
| LabReviewMicroSampleData.xml |
Microbiology extension sample data in
XML format |
| LabReviewMicroSampleData.dat |
Microbiology extension sample data for
use with SAS and ASCII |
The following files document the ECG Extension
and are posted as drafts for comment.
| LabReviewECGSpecification.xls |
The Lab Model ECG review
version specification in pdf format. |
| LabReviewECGDataFields.xls |
The Lab Microbiology extension data fields
in Excel spreadsheet format. |
The following files document the Reference
Range Model and are posted as drafts for comment.
Lab1-0-1RefRangeDefinition.xls
|
An Excel spreadsheet with
the basic definition of the model |
| Lab1-0-1RefRangeSpecification.pdf |
A PDF document with a more complete description
of the model |
Lab1-0-1RefRangeSchema.xsd
|
The XML schema for the model |
| Lab1-0-1RefRangeSchema
Documentation.doc |
A Word document with the model and documentation
for the XML schema |
| Lab1-0-1RefRangeSampleData.xml |
An XML file with sample data |
| Lab1-0-1RefRangeSampleData.txt |
An ASCII file with the same sample data
as in the XML file |
| Lab1-0-1RefRangeSampleData.xpt |
A SAS transport data set with the same
sample data as in the XML and ASCII files |
| LabRefRange1-0-1.zip |
A zip file that contains the 7 Reference
Range documents in this review release. |
The following file contains a template for
reporting a Case Study to the Lab team:
| LabModelCaseStudyTemplate.doc |
Template for reporting case
studies to the LAB team. |
CDISC Common LOINC Tests
| CDISCCommonLOINCTests.doc
|
This
table is a subset of the LOINC® database
terms that have been identified by 3 central
laboratories as the most frequently used
terms in clinical trials. The document
also contains further instructions for
accessing LOINC.
|
Go
to CDISC Public Discussion Forums
|
