Learn from standards experts during our monthly webinars.

 

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

CDISC Public Webinar: Type 1 Diabetes - Exercise and Prevention Scoping Summary

Date and Time:

TUE, 12 MAR 2019, 10:00 AM - 10:30 AM Central US Standard Time | 3:00 PM - 3:30 PM (GMT London Time)

Description:

This public webinar will share results from the Scoping Process in the development of a standard for Exercise and Prevention in Type 1 Diabetes. Scoping is part of the CDISC Standards Development Process to ensure the project is well defined with clear and achievable requirements and goals. The process typically includes background research, building a list of requirements, checking regulatory requirements and conducting a search of public databases to assess the most important clinical concepts and reduce duplication of effort. Next steps will be concept modelling and standards development.

With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC will extend already published diabetes standards to develop machine-readable metadata in the following Diabetes focus areas: Pediatrics, Devices, Prevention, and Exercise.

Presenter: 

  • John Owen, Consultant Project Manager

Webinar Language: English

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CDISC Library Launch

Date and Time:
THURS, 21 FEB 2019, 10:00 AM - 11:30 AM (Beijing); 11:00 AM - 12:30 PM (Tokyo)

Description:

CDISC Library (formerly known as CDISC SHARE), CDISC’s metadata repository (MDR), provides users with machine-readable versions of CDISC standards. CDISC Library includes a number of significant improvements over 1.0.

This webinar will demonstrate new features of CDISC Library , including a new application programming interface (API) and standards development tools. The API provides access to an expanded metadata model and new standards content. We will showcase API examples to highlight core new features.

The API is available to all CDISC members. As it is our commitment to increase access to CDISC Library, community and developer licenses will also be available. We will discuss details of these access options during the webinar, along with the roadmap of planned new content and features.

Presenter: 

  • Anthony Chow, Director, Data Science, CDISC
  • Sam Hume, VP, Data Science, CDISC
  • Mike Hamidi, Head of Data Science, CDISC

Webinar Language: English

 

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Members Only Webinar: Visual Define-XML Editor

TUE, 5 FEB 2019, 10:00 AM - 11:30 AM Central Standard Time

Description:

This webinar will discuss challenges arising in the Define-XML generation process and ways to address these challenges using Visual Define-XML Editor. Visual Define-XML Editor is a free and open-source project to develop new, and edit existing, files generated using the CDISC Define-XML 2.0 and ARM 1.0 standards.

The webinar will feature an overview of the Define-XML structures and associated complexities when representing these structures in a tabular view. It will also discuss when to create Define-XML files and show the Editor’s main concepts and functionality.

Panelists:

Dmitry Kolosov, Statistical Programmer

Webinar Language: English

 

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CDISC Public Webinar: Package 36 Controlled Terminology Publication Update/Package 37 Public Review

Date and Time:
WED, 9 JAN 2019, 1:00 PM - 2:00 PM Central Standard Time

Description:

This webinar will present an overview of the Package 36 Controlled Terminology publication update for SEND, Protocol, CDASH, SDTM, ADaM, and Glossary  2018-12-21 as well as an overview of Package 37, which is currently out for public review.

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

Panelists:

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

Webinar Language: English

 

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The Introduction and Implementation of ODM and Define.xml

Date and Time:
FRI, 14 DEC 2018, 10:00 AM - 11:00 AM China Standard Time (THU, 13 Dec 2018, 20:00-21:00, USA Central Standard Time)

Description:

描述:该主题主要信息来自CDISC的ODM/Define.xml标准的资深讲师Sally Cassells在CDISC 公开培训课中的资料,由CDISC授权给C3C用于中国的网络研讨会。
-  ODM
-  ODM概述
-  ODM1.3.2的具体内容
-  ODM的具体应用案例
-  Define.xml
-  Define.xml概述
-  Define.xml 2.0的具体内容
-  Define.xml的具体应用案例(SDTM, ADAM等)
 

讲者:该网络研讨会讲者彭瑞玲,现为CDISC中国(C3C)的副主席,是ODM/Define.xml的在认证讲师,C3C中ODM/Define.xml小组长。彭瑞玲来自北京医普科诺科技有限公司,是该公司创始人兼总经理,有着丰富的数据管理、EDC 和CDISC标准的应用经验。

Description: This webinar will address CDISC public training materials, authored with Sally Cassells (senior instructor of ODM/Define.xml), authorized by CDISC to C3C for this webinar and include the following topics:
-  ODM 
-  Introduction of ODM
-  Details of ODM1.3.2 
-  Use cases of ODM
-  Define.xml
-  Introduction of Define.xml 
-  Details of Define.xml 2.0
-  Use cases of Define.xml (SDTM ,ADAM,Dataset.xml) 
 

Presenter: Ruiling Peng is Vice President of C3C, a CDISC-authorized instructor of ODM/Define.xml, lead of the C3C ODM/Define.xml team, and founder and CEO of Beijing Improve-Quality Tech Co., Ltd. She has extensive experience in data management, EDC systems and CDISC implementation.
 

Webinar Language: Mandarin

 

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Call for Volunteers: New CDISC TA Projects Starting - Psoriasis, Congestive Heart Failure, Acute Kidney Injury

Date and Time:
TUE, 30 Oct 2018, 1:00 PM - 2:00 PM Central Daylight Time

Description:

CDISC recently received three grants to commence development work to extend CDISC foundational standards to include core Biomedical Concepts for three new therapeutic areas. These therapeutic areas are Psoriasis, Congestive Heart Failure and Acute Kidney Injury. Each of these projects will be approximately two years in duration and include the development of up to ten new end to end (CDASH, SDTM, ADaM) biomedical concepts, controlled terminology, and a number of questionnaires, ratings and scales as prioritized by team members. 

This is an invitation for your companies to volunteer to work directly with the FDA and CDISC in shaping submission standards for these important therapeutic areas. 

The Ask: We need volunteer TA clinical experts, clinical statistical experts and data standards experts to review concept listings to ensure that we have identified the right concepts and have defined them correctly during the scoping stage, and later to participate in the reviews and comment resolution stages of the development process. Since CDISC will do the actual metadata development, these roles are consultative in nature and will require only a minimal time commitment at certain points in the process. 

Panelists:

  • Rhonda Facile, VP, Development Opportunities, CDISC
  • Alana St. Clair, Associate Project Manager, CDISC
  •  

Webinar Lanaguage: English

 

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CDISC Public Webinar: ADaM Implementation - New Parameter vs. New Analysis Timepoint

Date and Time:

Date and Time:
THU, 19 Oct 2018, 10:00 AM - 11:00 AM China Standard Time

Description:

本次主题和讲师介绍: 
ADaM实战:新参数 vs 新分析时点 ADaM implementation: New Parameter vs New AnalysisTimepoint 
在ADaM实施中,新手经常会感到很困扰:到底是创建一个新的“参数”,还是新的“分析时间点”?在本次课程中,我们将通过范例,来详解如何选择的规则。 
 

Panelists:

  • Victor Wu吴崇胜:CDISC中国(C3C)现任主席,SDTM与ADaM认证讲师;迪时咨询(Data Science Express)公司创立者,超过10年的CDASH/SDTM/ADaM标准应用经验。

Webinar Lanaguage: Chinese (简体中文)

 

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CDISC Public Webinar - Standards Updates & Additions: Controlled Terminology Quarterly Updates - P35 Update; P36 Public Review

Date and Time:
FRI, 5 OCT 2018, 1:00 PM - 2:00 PM Central Daylight Time

Description:

This webinar will present an overview of the Package 35 Controlled Terminology publication update for SEND, Protocol, CDASH, and SDTM  2018-09-28 as well as an overview of Package 36, which is currently out for public review

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

Presenter:

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

Webinar Language: English

 

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Public Webinar: Controlled Terminology Mapping/Alignment Across Codelists

Date and Time:
TUE, 8 JAN 2019, 10:00 AM - 11:30 AM Central Standard Time

Description:

CDISC Controlled Terminology consists of questions (e.g., Variables, TESTs and PARMs) and answers (e.g., response codelists, qualifier variable codelists). Commonly referred to as codelists, these question and answer sets are published in an alphabetical listing within the CDISC terminology publication. The terms within these codelists may have relationships to other terms within other codelists. For instance, a single TEST in the EGTEST codelist may have a finite set of responses located in the EGSTRESC codelist that constitutes a subset of that codelist. These relationships are not readily apparent in the CDISC Controlled Terminology publication files.

To address this issue, the CDISC CT teams have created Codetable mapping files, which are supplemental files based off of published Terminology that show relationships between terms across different CDISC Controlled Terminology codelists.  These files provide human-readable linkages between published terms across multiple codelists and will soon be available in machine-readable formats. 

This webinar will discuss the contents of these codetable files, the purpose and uses of these supplemental resources, and how to access the machine-readable formats.
 

Presenter: 

  • Anthony Chow, Director of SHARE, CDISC
  • Erin Muhlbradt, Clinical/Biomedical Information Specialist, MSC
  • Donna Sattler, Consultant, Data Standards, J&J

 

Webinar Language: English

 

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Members Only Mini-Training Series: What’s a Disease Milestone and Why Would I Want One?

Date and Time:
THU, 13 DEC 2018, 10:00 AM - 11:30 AM Central Standard Time

Description:

Disease milestones are a new idea introduced in the upcoming release of SDTMIG v3.3. This webinar will explain how things that act as triggers for data collection in a study can be defined as “disease milestones” for that study to allow better description of the timing of SDTM records. It will also include examples that show the use of the new disease milestones datasets and timing variables. 

Presenter:

  • Diane Wold, Sr. Director, Standards Development and Modeling, CDISC

Webinar Language: English

 

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