The Clinical Data Acquisition Standards Harmonization (CDASH) model standardizes the way data is collected to facilitate the generation of SDTM tables.
As the primary aim of following CDASH Guidance is to make easier and more comfortable to transform raw study data into SDTM domains, CDASH is taken into consideration during CRF (and eCRF) design.
Information sharing on the content of SDTM in a more or less human-readable manner led to introduction of Define.xml, which – in short – contains all SDTM data AND metadata in XML-format.
The Standard content of define.XML is: Data Metadata (TOC), Variable Metadata, Variable Value Level Metadata, (Computational Algorithms), Controlled Terminology/Code Lists, Annotated CRF, Optional: Supplemental Data Definition Document.
Preparation of SDTM domains is quite a well defined procedure, which primarily means the proper application of the guidance in case of the standard variables and domains (e.g. sex, age or blood pressure). Due to the nature of SDTM even the study or therapeutic area specific variables can easily been transformed into SDTM-compliant variables with following the naming and formatting conventions.
Tables, Listings and Graphs are defined in the Statistical Analysis Plan with the help of Table Shells. Theoretically table shells defines the outputs with character precision (in case of Tables and Listings).
Planimeter developed a highly sophisticated SAS-macro set which is able to deliver the required outputs with very high flexibility. What is the best in our solution that the macro set can be adjusted through an interface which does not require programing knowledge.
SDTM and ADaM data sets are programmed according to the associated specifications, and validated against a series of electronic integrity checks to ensure compliance to the models.
Additional QC includes independent verification of results.
In the Subject-Level Analysis Dataset (ADSL) only one record is created for all subjects.
Quality Assurance Procedures
Steps establishing quality during development phase: Application of programing conventions, Commenting and segmenting, Application of continuously developed macros in TLG-derivation, Double programming on demand, TLG-derivation in a three-stage method: development, testing, production, Complete and transparent documentation of the whole activity (code development and QA), Continuous development of standardization according to international standards and guidelines.