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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.


Date and Time:
THU, 11 APR 2019, 10:00 AM - 11:30 AM Central US Standard Time | 4:00 PM - 5:30 PM (GMT London Time)

Description:

This webinar will provide a forum to ask panelists any questions regarding the development of QRS terminology and supplements. Examples of questions recently received include:
•    Please explain the organization of the new Controlled Terminology and Questionnaires, Ratings, and Scales pages on the CDISC website?
•    What are the rules for determining if a supplement should be in the Disease Response and Clin Classification (RS) domain?
•    What are our QRS naming rules for terminology?
•    How do we determine FACT/FACIT synonyms and terminology?
•    What is the status of ADQRS supplement development? 
•    Will there be controlled terminology to go with ADQRS supplements?
•    Since I have an SDTM QS dataset for my clinical study, how many ADQS datasets should I create?

Please submit questions in advance on the webinar registration page; this will allow us to prepare examples in our responses. Panelists will also receive additional questions during the webinar and inform attendees of the latest news in QRS development.

Panelists: 

  • Dana Booth, SDS QRS Subteam Co-Lead
  • Nancy Brucken, ADaM ADQRS Subteam Co-Lead
  • Steve Kopko, SDS QRS Subteam Co-Lead
  • Karin LaPann, ADaM ADQRS Subteam Co-Lead
  • Jordan Li, QRS Controlled Terminology Team Lead

Webinar Language: English

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Date and Time:
TUE, 16 APR 2019, 10:00 AM - 11:00 AM Central Standard Time

Description:

This webinar will include a description of the P38 publication, including changes that occurred post-public review, and the P39 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.

Panelists:

  • Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC
  • Chris Gemma, Project Manager, CDISC

Webinar Language: English

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Date and Time:

THU, 18 APR 2019, 10:00 AM - 11:30 AM Central US Standard Time | 4:00 pm - 5:30 PM (London)

Description:

This webinar will highlight the changes in version 1.2 of the ADaM Implementation Guide, which is scheduled to be published this year. Changes include important clarifications to existing text, standard nomenclature for stratification variables within ADSL, and a recommended approach for bi-directional toxicity grades. We will also discuss the removal of PARQUAL, which had been included in the document when it went out for Public Review.

Additionally, the webinar will discuss ADaM Integration, which supplements the published ADaM standards and presents general considerations for integration. New ADaM structures, allowing for complex integrations with multiple records per subject in an integrated ADSL, will be presented. A method for handling simple integrations will also be described.

Presenters:

  • Brian Harris, Director of Biometrics Operations, MedImmune (AstraZeneca)
  • Terek Peterson, Senior Director of Global Statistical Standards, Chiltern
  • Deborah Bauer, Assistant Director, Sanofi

Webinar Language: English

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Date and Time:

THU, 25 APR 2019, 12:00 PM - 1:00 PM Central US Standard Time | 5:00 PM - 6:00 PM (GMT London Time)

Description:

For decades, CDISC has worked hand-in-hand with our global community of member organizations to facilitate the development of standards that are open and available to all. Together, we enable the accessibility, interoperability, and reusability of data for more meaningful and efficient research that has greater impact on global health.

Join us for a webinar to learn more about the work CDISC is doing with the support of our membership as well as the many benefits of being a CDISC member so that you can make the most of your membership.

Audience:
·         Employees of CDISC Member organizations.
·         Those interested in bringing clarity to clinical research data and amplifying  its impact.

Panelists:
·         Sheila Leaman, Vice President of Membership and Events, CDISC
·         John Ezzell, Head of Education Development, CDISC

Webinar Language: English

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Date and Time:
TUE, 9 JUL 2019, 10:00 AM - 11:00 AM Central Standard Time

Description:

This webinar will include a description of the P39 publication, including changes that occurred post-public review, and the P40 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.

Panelists:

  • Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC
  • Chris Gemma, Project Manager, CDISC

Webinar Language: English

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Date and Time:
TUE, 1 OCT 2019, 11:00 AM - 12:00 PM Central Standard Time

Description:

This webinar will include a description of the P40 publication, including changes that occurred post-public review, and the P41 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.

Panelists:

  • Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC
  • Chris Gemma, Project Manager, CDISC

Webinar Language: English

Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by LogMeIn).