Experiences and lessons learned from a first SDTM submission project
Paul Vervuren, Bas van Bakel · 2009
This paper presents the experiences and the lessons learned from an SDTM conversion project. Within the scope of this project were (1) the late-stage conversion of datasets in internal standard to SDTM, (2) the creation of Trial Design datasets, (3) the development of macros to create define.xml and define.pdf, (4) the actual creation of these data definition files, and (5) the creation of SDTM annotated CRFs. Topics covered are the project strategy and our approach to the development of define.xml and define.pdf. We will present details of the conversion process and give examples of challenging domain implementations. Moreover, we will discuss the results of WebSDM TM checks performed as part a sample submission. Finally, the activity metrics of the project are presented.