What are the different approaches for creating the SDTM 3?
There are 3 general approaches to create the SDTM datasets: a) Build the SDTM entirely in the CDMS, b) Build the SDTM entirely on the “back-end” in SAS, c) or take a hybrid approach and build the SDTM partially in the CDMS and partially in SAS. BUILD THE SDTM ENTIRELY IN THE CDMS It is possible to build the SDTM entirely within the CDMS. If the CDMS allows for broad structural control of the underlying database, then you could build your eCRF or CRF based clinical database to SDTM standards. Advantages: • Your “raw” database is equivalent to your SDTM which provides the most elegant solution. • Your clinical data management staff will be able to converse with end-users/sponsors about the data easily since your clinical data manager and the und-user/sponsor will both be looking at SDTM datasets. • As soon as the CDMS database is built, the SDTM datasets are available. Disadvantages: • This approach may be cost prohibitive. Forcing the CDMS to create the SDTM structures may simply be too
