Validating controlled terminology in sdtm domains tips on asian dating

The mapping of (local) lab test codes to the lab test controlled terminology in CDISC-SDTM can be challenging.

With the wording of Paul Vervuren: "One has to find candidates in the extensive controlled terminology list.

CDISC however does not allow (yet) to use LOINC codes for use in LBTESTCD, this although the LOINC code uniquely describes the lab test, which the CDISC controlled terminology for LBTESTCD does not at all, even not when in combination with LBCAT, LBSPEC, LBMETHOD, ... The LOINC code 73710-6 uniquely defines the test "Weed Allergen Mix 209 (Common ragweed Western ragweed Giant ragweed) Ig E Ab [Units/volume] in Serum by Multidisk".

So unfortunately, we need to map from a universal system (LOINC) to a local system (only used in submissions). It is usually measured in k[IU]/L (thousand international units per liter).

This supplement supports ADa M Implementation Guide (IG) v 1.1.ARM v1.0 for Define-XML v2 supports the submission of ARMas defined in ADa M v2.1.The release package consists of a zip file that includes a readme file, the specification document, an ADa M-based Define-XML example and the ARM schema.The ADa MIG must be used in close concert with the ADa M document v2.1.ADa M OCCDS v1.0 is based on ADa M Version 2.1 and the ADa MIG v1.1.

Leave a Reply