Learn from standards experts during our monthly webinars.

 

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

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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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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