Upcoming Webinars

Webinars address industry hot topics, best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts. For more information about CDISC webinars, please reach out to us at cdiscwebinar@cdisc.org

Define-XML Office Hours

17 February 2022, 11am - 12:30pm EST

REGISTER NOW!


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.


Panelist(s)

Sam Hume, VP, Data Science, CDISC
Lex Jansen, Principal Solution Consultant, CDISC
Jozef Aerts, Director, XML 4 Pharma
Marcelina Hungria, Managing Director/Owner, DIcore Group
Dmitry Kolosov, Expert Statistical Programmer, Parexel

Language

English

Controlled Terminology Office Hours

15 March 2022, 11am - 12:30pm EDT

REGISTER NOW!


Ask panelists any questions regarding the development and implementation of Controlled Terminology. 


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 Controlled Terminology development.


Panelist(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
Jordan Li, Biomedical/Clinical Research Information Specialist Enterprise Vocabulary Services (EVS), National Cancer Institute Contractor
Craig Zwickl, Terminology Specialist, CDISC

Language

English


This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.


Panelist(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Language

English


This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.


Panelist(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Language

English


This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.


Panelist(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Language

English


This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.


Panelist(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Language

English