Learn from standards experts during our monthly webinars.

 

Access to past webinars can be found at the bottom of this page.

CDISC 360: The Journey So Far and the Road Ahead

Date and Time:
TUE, 28 APR 2020, 10:00 AM - 11:30 AM Central US Standard Time

Description:
Join CDISC leaders for an exclusive look at the ongoing development of CDISC 360. Presenters will review project milestones, including development of the concept-based standards model, content from this model stored in CDISC Library, and the results of project execution use cases based on this content. Presenters will also discuss CDISC 360 project goals and how attendees can benefit from, and contribute to, this transformative project.

Presenters: 

  • Sam Hume, Vice President of Data Science, CDISC
  • Peter Van Reusel, Chief Standards Officer, CDISC

Webinar Language: English

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CDISC Initiatives Webinar

Date and Time:
TUE, 3 MAR 2020, 10:00 AM - 11:30 AM Central US Standard Time

Description:

Learn about CDISC’s ongoing, transformative initiatives that will benefit the CDISC community and modernize clinical research. Join CDISC leaders as they discuss:

Presenters:
•    Peter Van Reusel, CDISC Chief Standards Officer
•    Rhonda Facile, CDISC Vice President of Development Opportunities 
•    Bess LeRoy, CDISC Head of Standards Development
•    Mike Hamidi, CDISC Head of Data Science 

Webinar Language: English

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CDASH Office Hours

Date and Time:
THU, 16 APR 2020, 10:00 AM - 11:30 AM Central US Standard Time

Description:

Ask panelists any questions regarding the development and implementation  of CDASH, CDISC’s standard for data collection. Examples of questions recently received include:

  • Do we have to use the ddMONyyyy date format?
  • Do we have to store the date that way?
  • Why does the CDASH IG keep referring to SDTM? My job is just to collect the data.
  • What does “traceability” actually mean, and how do we do it in CDASH?

There is a space on the webinar registration page to submit your questions in advance so that our panelists can prepare responses. Panelists will also receive questions during the webinar and inform attendees of the latest news in CDASH development.
 
Panelists:
Bess LeRoy, Head of Standards Development, CDISC
Kit Howard, Sr. Director, Standards Development and Education, CDISC
Gary Walker, CDASH Instructor and Development Team Member, CDISC

Webinar Language: English

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Public Review Webinar: Chinese Translations of SDTMIG v3.2, ADaMIG v1.1, ADaM OCCDS v1.0, ADaM v2.1

WED 5 FEB 2020, 11 AM - 12:30 PM China Standard Time

Description:

本次网络研讨会,C3C的张胜林将为大家讲解,将涵盖以下内容:

-中文翻译稿涵盖的CDISC标准: SDTMIG v3.2, ADaMIG v1.1 (以及OCCDS v1.0和ADaM v2.1)

-征求意见稿的时间表:分批次审阅。首批1月20日至2020年3月20日截止。下一批时间表。

-征求意见的形式:采用CDISC官方的Wiki+Jira。并走正式的公众审阅的流程。

-收集意见之后修改的内容发布计划。

-未来CDISC标准的中文翻译稿计划。

-演示如何在Wiki提意见。

On this webinar, Shenglin Zhang from Chinese CDISC Coordinationg Committee (C3C) will cover:

  • The Chinese translations for Public Review of SDTMIG v3.2, ADaMIG v1.1 (including ADaM OCCDS v1.0 and ADaM v2.1)
  • Public Review Timeline first batch Jan 20th to Mar 20th. 
  • The publishing plan after the Public Review is complete.
  • Chinese translations for future CDISC standards versions.
  • Demo on how to submit comments on the CDISC Wiki.

Panelists:

  • Chao Wang,Director of Statistical Programming, FMD K & L
  • John Wang, Associate Director, Statistical Analysis,  dMed Biopharmaceutical Co.
  • Victor Wu, Co-founder, Beijing Data Science Express Consulting Co., Ltd.
  • Shenglin Zhang, Director of Biostatistics, Taimei Medical Technology

Webinar Language: Chinese

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CDISC for Newcomers - Are You New Here?

Date and Time:
TUE, 7 JAN 2020, 10:00 AM - 11:30 AM Central US Standard Time

Description:
New to the world of CDISC Standards? This webinar will cover the fundamentals of CDISC, including:

  • An overview of the data models
  • Regulatory requirements
  • Use cases for CDISC Standards
  • The need for global standards in the current industry environment

Presenter: 
John Owen, Consultant Project Manager, CDISC 

 

Webinar Language: English

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Controlled Terminology Updates for Q4

Date and Time:
TUE, 13 OCT 2020, 10:00 AM - 11:30 PM Central Standard Time

Description:

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.

Panelists:
​Dr. Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC

Webinar Language: English

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Controlled Terminology Updates for Q3

Date and Time:
TUE, 7 JUL 2020, 10:00 AM - 11:30 PM Central Standard Time

Description:

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.

Panelists:
​Dr. Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC

Webinar Language: English

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Controlled Terminology Updates for Q2

Date and Time:
TUE, 14 APR 2020, 10:00 AM - 11:30 PM Central Standard Time

Description:

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.

Panelists:
​Dr. Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC

Webinar Language: English

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Controlled Terminology Updates for Q1

Date and Time:
TUE, 14 JAN 2020, 10:00 AM - 11:30 PM Central Standard Time

Description:

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.

Panelists:
Dr. Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC

Webinar Language: English

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Psoriasis Therapeutic Area User Guide Public Review

Date and Time:
THU, 23 JAN 2020, 10:00 AM - 11:30 AM Central US Standard Time

Description:
According to the World Psoriasis Day consortium, 125 million people worldwide have psoriasis. Join CDISC for our webinar to introduce the Therapeutic Area User Guide (TAUG) for psoriasis to the CDISC community for Public Review. CDISC TAUGs provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

We will run through highlights of the guide as well as known Issues, which need your expertise. Come with your questions.

CDISC relies on your input and expertise during the Public Review period to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community.

Presenters: 
Alana St. Clair, Project Manager, CDISC
Jon Neville, Sr. Standards Developer, CDISC
Kathleen Mellars, Contractor, CDISC
Diane Corey, Data Manager Standards Developer, C-Path

Webinar Language: English

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