Validating controlled terminology in sdtm domains

ADa M Validation Checks v1.3 correspond to the ADa MIG v1.0, Adverse Events (ADAE), and Basic Data Structure for Time-to-Event Analyses (BDS-TTE).All changes and updates are described in Appendix A. 75 new checks regarding ADAE and BDS-TTE have been added.

ADa MIG v 1.1 updates Version 1.0 with clarifications, corrections, new variables, additional examples, and references to current documents.

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.

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.

Leave a Reply