LAB

The CDISC LAB Base Model Version 1.0.1 is being released to industry for implementation. The last update incorporated 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 released the final XML schema representation of the model for implementation. In addition, sample datasets were 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.

• LabModelReleaseNotes (pdf) Description of this release.
• LabModel.zip Zip file of all files in this relase

The following files document the Base model Version V1.0.1 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 (Currently Unavailable) 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.