Formedix at #OC17

//Formedix at #OC17

Join him in the Bangkok-Hanoi room on Monday December 4th at 4pm.


In December 2016, the FDA passed regulation requiring that new drug submissions contain clinical trial datasets that conform to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation (SDTM) standards. However, CDISC standards are not just about regulation. They can save time and money in the set-up, conduct, and submission of clinical trial data.  This session will compare and contrast a traditional SDTM dataset conversion process performed by 2 teams of SAS programmers versus a CDISC metadata driven approach which uses CDISC Define.xml in novel ways to:

  1. automate source, target and mapping specification creation,
  2. give dataset conversion engines study specific transformation instructions, and
  3. eliminate manual coding.

We will show how this CDISC metadata driven approach with Define.xml has lowered CDISC SDTM conversion times by 70%.  The final part of our presentation will look at additional SDTM conversion scaling strategies that can be implemented in order to (a) reduce mapping effort on a study-by-study basis and (b) support multiple SDTM versions.