Validating controlled terminology in sdtm domains
At the same time, the file needs to be constructed and kept in sync with the designed mapping.Furthermore, the mapping needs to be executed on the available clinical data and an SDTM database created and populated.(1.0 or 2.0) details can then be added using intelligent wizards (no user-unfriendly Excel files necessary). wanted a software package to transform ODM metadata and clinical data into SDTM format, this in order to build databases and data warehouses, needed to be able to compare clinical studies of the different partners in the academic network.software is the further development of the "SDTMWandler" ("SDTM Transformer") a software package developed for, and in close cooperation with TMF e. ("Telematikplattform fr Medizinische Forschungsnetze e. V."), the German Informatics/Telecommunication Platform for Medical Research Networks. acts on CDISC ODM files (v.1.2, 1.3 or 1.3.1) which can easily be exported from any modern EDC, CDM system or database (the CDISC ODM standard is THE exchange format for clinical data between sponsors, CROs and the FDA).
The column "Controlled Terms, Codelist or Format" in the SDTM IG and the column "Codelist / Controlled Terms" in the ADa M IG are generally a good reference when deciding on the need for a CT for a specific variable.
In our experience, one day of training usually suffices to make a jumpstart with the software.
Such trainings are of course offered by us, usually at the location of the customer.
For many variables (e.g., SEX, RACE, AESEV) the valid values are defined in the NCI/CDISC Terminology files.
For other variables (e.g., SEXN, PARAMCD, PARAM) it is up to the producer to define the valid values of those variables.