How Do I Map That? - SDTM Implementation Challenges

In many cases the mapping of a Case Report Form (CRF) page to the appropriate Study Data Tabulation Model (SDTM) domain and variables is relatively straightforward, especially if the CRF has been designed with SDTM in mind. However, there are situations where the data that is collected within a clinical study does not have an obvious mapping to either a standard or sponsor defined domain. This paper will look at some data collection scenarios encountered on a legacy Phase III Rheumatoid Arthritis study and examine some of potential mapping solutions considered, as well as the reasons behind the decision for the chosen option. It will also describe some of the lessons learnt, which were then applied on a more general level to the SDTM mapping. DISCLAIMER All views expressed in the paper are those of the author and not necessarily those of Roche Products Ltd.