Learn from standards experts during our monthly webinars.

 

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

CDISC Standards: Myths and Truths

Date:
TUE 3 DEC 2019 - 10:00-11:30AM CST

Description:
Join CDISC veterans Kit Howard and Dr. Erin Muhlbradt as they discuss common misconceptions about CDISC standards, dispel myths, and drop lesser-known truths on our audience.

More details coming soon, but don't let that stop you from registering now!

Panelists:
Kit Howard, Sr. Director, Standards Development and Education, CDISC
Dr. Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC

Webinar Language: English

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CDISC Strategic Plan: Clear Vision, Clear Impact

Date:
TUE 18 FEB 2020 - 10:00-11:30AM CST

Description:
CDISC is embarking on a journey of change. Join President and CEO David R. Bobbitt as he presents the CDISC Strategic Plan 2019-2022. This presentation focuses on:

  • How will CDISC respond to new sources of data and new technologies?
  • How should we build and deploy standards?
  • What work must CDISC engage partners?
  • How will CDISC support member companies and those who utilize CDISC standards?
  • What is CDISC’s plan for global utilization of the standards?
  • How will CDISC support academics and others who utilize CDISC standards outside the traditional sponsor-regulator use case?

Panelist:
David Bobbitt, President & CEO, CDISC

Webinar Language: English

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Why Data Sharing and Data Standardization Matter

Date & Time:
THU, 10 OCT 2019, 10:00AM - 11:30AM CST

Description:
CDISC and Vivli are presenting an exclusive conversation with Vivli Executive Director Dr. Rebecca Li, UCSF professor and Vivli Co-Founder Dr. Ida Sim, and CDISC President and CEO David R. Bobbitt who will discuss how data sharing and data standardization go hand-in-hand in the quest to move scientific discovery forward.

Topics will include:
-The importance of data sharing and shifting the data sharing landscape
-How to increase data utility:  the benefits of data standardization
-Working together  

Vivli is an independent, non-profit organization that has developed a global data-sharing and analytics platform. Their focus is on sharing individual participant-level data from completed clinical trials to serve the international research community.

Presenters:
David Bobbitt, President & CEO, CDISC
Dr. Rebecca Li, Co-Founder, Vivli
Dr. Ida Sim, Co-Founder, Vivli; Professor of Medicine, University of California, San Francisco

Webinar Language: English

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Type 1 Diabetes Therapeutic Area User Guide Public Review

Date and Time:
Tue, 10 Sep 2019, 10:00 AM - 11:00 AM Central Daylight Time

Description:

Building on the already published Diabetes Standards, and with the support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC is developing standards for T1D to enable data sharing, cross-study comparisons and meta-analysis, increasing efficiency in research to accelerate development of potential new therapies as well as finding new scientific links within and between disease areas. The ultimate goal is to improve the lives of people living with T1D, and identifying strategies to prevent its onset.

The development of the standards has been divided into three phases.

  • Pediatrics and Devices
  • Exercise
  • Prevention

This Public Review addresses the first phase – Pediatrics and Devices.

View the standard: TAUG-T1D

We strongly encourage your participation in this review to provide your comments to ensure that the final published standards can be used by the largest implementer base.

Panelists:

  • John Owen, Consultant Project Manager, CDISC

Webinar Lanaguage: English

 

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Crohn’s Disease Therapeutic Area User Guide Summary of Scoping Results

Date and Time:
Thu, 19 Sep 2019, 10:00 AM - 11:00 AM Central Daylight Time

Description:

CDISC, with support from The Leona M. and Harry B. Helmsley Charitable Trust, is developing the first global, non-proprietary clinical data standards for Crohn’s disease to improve the quality, usefulness, consistency, sharing and mutual understanding of clinical data. Once developed, the clinical data standards will increase the efficiency and collaboration within research and clinical development to better address the unmet medical needs of patients. These standards will also provide the tools to further support Helmsley's data sharing priorities. 

This webinar will present a summary of the topics planned for standards development for version 1.0 of the standards. The identified scope will focus on the key biomedical concepts that will provide the most useful information to the broadest implementer base.

Panelists:

  • John Owen, Consultant Project Manager, CDISC

Webinar Lanaguage: English

 

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CDISC Members Only Mini-Training: SEND Trial Sets in Human Clinical Trials

Date & Time:
17 SEP 2019 @ 10:00 AM - 11:30 AM CST

Description:
CDISC’s Standard for the Exchange of Nonclinical Data Implementation Guide (SENDIG) contains domains for general toxicology, pharmacology, and carcinogenicity studies.  This webinar will address cases where concepts developed for non-clinical trials may be useful for human clinical trials and will provide an insight into non-clinical practices and procedures, with a focus on their similarities and differences.

Presenters:
Diane Wold, Senior Director, Standards Development, CDISC
Fred Wood, Vice President for Consulting Services, TalentMine

Webinar Language: English

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Updates of CDISC Standards SDTM v1.7/SDTMIG v3.3 (Chinese Language)

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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Therapeutic Area (TA) Standards Overview

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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CDASH v2.1 and SENDIG v3.1.1 Public Reviews

Date and Time:
TUE, 28 MAY 2019, 10:00 AM - 11:30 AM Central US Standard Time

CDASH v2.1 Public Review - A walk through the changes made to the CDASH Model v1.1 and CDASH Implementation Guide v2.1, from their respective prior version published in September 2017.

Presenter:  
Mike Ward, Clinical Data Standards Consultant, Eli Lilly & Company

SENDIG v3.1.1 Public Review -  Addresses various pressing issues with the current definition of the PC and PP domains for SEND. The presentation will describe the key differences from SENDIG v3.1, the justification and background for these changes, and the deliberately limited scope of this release.

Panelists:
Marc Ellison, Director, SEND Solutions, Instem
Erin Tibbs-Sloane, SEND Data Associate, Charles River
Christy Kubin, Associate Director, SEND, Charles River

Webinar Language: English

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A Sneak Peek at the New Features and Capabilities of ODM v2.0

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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