Implementation of CDISC ADaM in the Pharmacokinetics department
Joanna Magielse · 2014
SGS Life Science Services as a leading CRO, is one of the pioneers in the implementation of CDISC standards. Given the positive experiences in the SGS Data Management and Biostatistics departments (implementation of SDTM and ADaM respectively), the Pharmacokinetics (PK) Department recently decided to adopt the CDISC standards as well. In an SDTM database, pharmacokinetic data is stored as one record per subject, per time point (PC domain) or per pharmacokinetic parameter (PP domain). For the PK analysis, the generation of Tables, Listings and Figures, and the statistical analysis on PK parameters, ‘analysis ready’ datasets are created. The structure of these ‘analysis ready’ datasets is based upon the Basic Data Structure (BDS) of CDISC ADaM. This paper will highlight a practical approach in converting PC into ADPC and PP into ADPP, with the focus on data handling, criteria evaluation and sub-analysis selection, important aspects of PK analysis.