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, 20 JUN 2019, 10:00 AM - 11:30 AM Central US Standard Time 
 
Description:
Therapeutic Area (TA) Standards extend the Foundational Standards to represent data that pertains to specific disease areas. TA Standards include disease-specific metadata, examples and guidance on implementing CDISC standards. To date, TA standards have been developed for over 30 disease areas.
This webinar will deliver a history of the TA Standard program and explain how CDISC works with partners and volunteers to develop these complex standards.
Using implementation examples, presenters will explain how implementers can effectively use the TA standards documents in both clinical trial and academic research.
Attendees will also learn about ongoing and upcoming CDISC TA Standard projects and how they can volunteer to develop them.
Additional Topics:
• TA Development Process
• Best Practices for using TAs
• How to comment during Public Review
• Upcoming/Ongoing TA Projects
• How to volunteer for TA development
 
Presenters:
John Owen, Project Manager, CDISC
Joe Ben Clark, IT Manager, CDISC
Alana St. Clair, Project Manager, CDISC
 
Webinar Language: English

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Date and Time:
FRI, 28 JUN 2019, 10:00 AM - 11:30 AM China Standard Time 9:00 PM - 10:30 PM US Central Standard Time

Description:
The release of SDTM v1.7/SDTMIG v3.3 brought significant changes and newly added content, reflecting the increasing changing requirements on clinical study data standards from industry, regulatory agencies and other stakeholders over the past several years. This webinar aims to provide a thorough understanding of SDTMv1.7/SDTMIG v3.3 so that users are well-prepared for implementation. 
Topics include:
Highlights of SDTM v1.7 and SDTMIG v3.3
Comparison between SDTMv1.4/SDTMIGvv3.2 and SDTM v1.7/SDTMIG v3.3
Considerations on implementation strategy

标题:CDISC数据标准更新:SDTM1.7/SDTMIG3.3介绍
简介:
最新的SDTM标准SDTM1.7 / SDTMIG3.3已于2018年11月20日正式发布,相较于5年前发布、目前广泛使用的SDTM1.4 / SDTMIG3.2标准,本次更新涵盖许多新的内容和变化,以适应行业、监管当局及其他利益相关方等对临床研究数据标准化与时俱进的要求。

本次网络研讨会的目的是帮助您更好地了解这一新版本,为即将的具体实施作好准备,主要包括以下三个主要部分:
•       SDTM1.7和SDTMIG3.3亮点介绍
•       SDTM1.4 / SDTMIG3.2和SDTM1.7 / SDTMIG3.3比较
•       关于具体实施策略的考虑

Presenters:
Stanley Wei, CDISC SDTM Instructor
Victor Wu, C3C Chair, Data Science
John Wang, C3C Vice Chair, dMed

Webinar Language: Chinese

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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:
THU, 25 JUL 2019, 10:00 AM - 11:30 AM Central US Standard Time 

Description:
Version 2.0 of ODM will provide many new capabilities, features, and improvements over v1.3.2. This webinar will demonstrate some the most important new features, including an ODM RESTful API, support for automated study designs, JSON support, data queries, content semantics, enhanced support for non-CRF data, enhanced support for dynamic CRFs,  improved traceability, and better support for translations. We will also highlight the role of ODM v2.0 in the CDISC 360 Project.

Panelists:
Sam Hume, Vice President, Data Science, CDISC
Sally Cassells, Sr Director, Data Exchange Standards and Certification, 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

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