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LAB

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 has been 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.

The following files document the Base model Version V1.0.1 and are being posted for implementation:

The following files document the XML schema implementation of the Base model and are posted as final versions for implementation:

The following files document the Microbiology Extension and are posted as drafts for comment:

The following files document the ECG Extension and are posted as drafts for comment.

The following files document the Reference Range Model and are posted as drafts for comment.

The following file contains a template for reporting a Case Study 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.
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