Define validating life
Although never asked for, I will also list what i.m.o. In the following, I will use SDTM a lot as an example, but usually the same applies to ADa M and SEND.If you are a sponsor outsourcing the generation of SDTM datasets (e.g.In the time needed to find out how that works, you could already have become an XML expert!Many people think that is what they see in the browser (using the stylesheet), not realizing (or not wanting to) that there is an XML file behind that, a file that is machine-readable and that can be used for much more than just displaying the study metadata.
So if your copy-and-paste from a Word document into an XML document, and you have characters that go beyond ASCII-7, be not surprised when you see the strangest things in the result.Learn XML or have someone in your team that has XML knowledge.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.There are several good software tools on the market for doing so.I have a customer who is even doing the complete mapping between ODM and SDTM long before the study starts, as a quality control for the study design.
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Even if your study has already started, it is a very good practice to do this mapping long before the database closes.