Define validating life

As long as such a tool allows you to validate your against the XML-Schema A bad practice that is often followed is to try to generate a file from a set of SDTM files (XPT files) using a "black box" tool (post-generation).You can use such a tool to generate a "first guess" of a file for your study, but you will still need either to edit it using an XML editor, or to use a tool mentioned before, to complete and fine-tune the Here is a slide set of my colleague Philippe Verplancke about this, even showing how a can be used as a direct source for CRF design for the next study.

My undergraduate students learn XML in just two lectures (each of 90 minutes), and one or two exercise afternoons. With a litte XML knowledge, you can generate a file for your SDTM datasets starting from an existing sample file (like the one published by the CDISC team). Use an XML editor (and not Note Pad or Word Pad or so - disaster is preprogrammed) - there are even some very good XML editors that are free.Unfortunately, most reviewers at the FDA do not realize this either.Some companies have similar processes in place where the is generated post-SDTM, usually using Excel worksheets, or even using Word documents.The idea is very simple: "if we cannot map the study design to SDTM now (before the study starts), we will be in big trouble later".The itself is used to store the mapping instructions.

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