Ask panelists any questions regarding the development and implementation of Define-XML, CDISC's Data Exchange standard, which transmits metadata that describes any tabular dataset structure. Define-XML is required by the US FDA and the Japan PMDA for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used. Example questions:
- I have a dataset in my submission for which intended data were to be collected, but none actually were. How do I handle this situation in my Define-XML file? Do I still include the dataset definition?
- Define-XML has a “Mandatory” attribute for variables. How does this relate to the Core attribute that I see in ADaM, SDTM and SEND Implementation Guides?
- Should I use the XLS stylesheet that was published as part of the Define-XML publication?
- I am trying to open my Define-XML file in Chrome, but it does not open. How can I solve this?
- When to create Value Level Metadata?
- Do I need to create a codelist for all variables with a finite number of values?
Submit your questions in advance on the webinar registration page. Panelists will also answer questions during the webinar as well as inform attendees of the latest news in Define-XML development.
- Sam Hume, VP, Data Science, CDISC
- Lex Jansen, Senior Director, Data Science Development, CDISC
- Jozef Aerts, Director, XML 4 Pharma
- Marcelina Hungria, Managing Director/Owner, DIcore Group
- Dmitry Kolosov, Expert Statistical Programmer, Parexel