Published Date:
CDISC has released the final version 1.0 of the MSG Package, which was originally released for public comment from 2010-05-14 to 2010-06-07. During that review period, over 570 comments were received, which needed to be resolved before this final package could be released. An appendix to SDTMIG v3.1.2 is included with the package to familiarize users with the SDTM submission components. Additionally, a sample electronic submission is included, which contains an annotated CRF, submission datasets compliant with the SDTMIG v3.1.2, a Define.xml file describing the structure and content of the submitted datasets, a stylesheet for visualizing the define.xml in a user-friendly way, and an optional reviewers’ guide.