Learn from standards experts during our monthly webinars.

 

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

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

Date & Time:
17 SEP 2019 @11:00 AM -12:30 PM ET

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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Members Only Mini-Training: Relative Timing Variables in CRFs

Date and Time:
THU, 23 MAY 2019, 11:00 AM - 12:30 PM Central US Standard Time

Description:
Data is often collected using terms like “prior” and “ongoing” when start and end dates are not known.  Those terms are not sufficient alone.  One needs to know what time “prior” or “ongoing” refers to. (Prior to what time?  Ongoing as of what time?) The SDTM variables –STRF and –ENRF were the first approach to dealing with converting “prior” or “ongoing” in collected data into terms that are clear in tabulations.  These variables describe the start and end of an event or intervention relative to the study reference period in the DM domain.  However, this approach can’t always be used, so new pairs of variables were introduced that can describe start or end relative to any point in time (--STRTPT and --STTPT, --ENRTPT and --ENTPT).

This webinar will help attendees understand the difference between the two sets of relative timing variables in SDTM and which to choose based on how data were collected.

Panelists: 

  • Diane Wold, Senior Director, Standards Development, CDISC
  • Kit Howard, Senior Director, Standards Development and Education, CDISC

Webinar Language: English

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Highlights of Define-XML 2.0 Implementation and FAQs

Date and Time:
FRI 19 APR 2019 @ 10:00 AM - 11:00 AM China Standard Time | THU 18 APR 9:00 PM - 10:00 PM Central US Standard Time

Description:
Define-XML is the metadata to describe study data (SDTM/ADaM) and ARM is the metadata to describe the tables or figures. Through structured representation, this type of metadata shows the data flow from raw data to analysis table or figure results, and provides clear data definition to regulatory reviewers.

By introducing the structure and related elements of Define-XML (ARM) as well as the development steps, review details, and implementation process in Chinese studies, this webinarwill address implementation recommendations and common implementation issues with the goal of further promoting the application of Define-XML in Chinese studies.

Define-XML是描述临床研究数据集(SDTM/ADaM)的元数据,ARM则是描述表格或图表的元数据。这类元数据通过结构化的表述,清晰呈现了从原始数据集到分析图表的数据流演变,为评审者提供清晰的数据定义。

通过介绍Define-XML(ARM)的结构及相关元素,制作生成步骤,检查审阅细节,中文项目实施建议及常见问题等,我们希望能够进一步推进Define-XML在中国项目上的实施与应用。

Panelists:
John Wang, AD, dMed
Victor Wu, VP, Data Science Express
Ruiling Peng, CEO, Improve Quality
 

Webinar Language: English

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Controlled Terminology Updates for Q4

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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Controlled Terminology Updates for Q3

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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ADaMIG v1.2 & ADaM Integration

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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