Learn from standards experts during our monthly webinars.

 

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

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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CDISC Standards Public Webinar: Nutrition TAUG Public Review

Date and Time:
THU, 18 Oct 2018, 10:00 AM - 10:45 AM Central Daylight Time

Description:

Public webinar to introduce the Therapeutic Area User Guide (TAUG) for Nutrition to the CDISC community for Public Review.  The purpose of TAUG-Nutrition is to describe how to use CDISC standards to represent data pertaining to nutrition studies. Version 1.0 focuses on infant nutrition, food and fluid intake, stool sampling, and questionnaires (specific to clinical studies in nutrition), and includes concepts for adult and pediatric populations. Public Review is a key quality step in the development of a thorough TAUG for the research community. We invite you to contribute your expertise.

Panelists:

  • John Owen, Consultant Project Manager, CDISC
  • Simon Lebeau, Data Manager, Danone Nutricia Research
  • Hanneke Lankheet, Danone Nutricia Research
  • Emilie Darcillon, Nestle

Webinar Lanaguage: English

 

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Type 1 Diabetes Scoping Results Webinar

Date and Time:
THU, 4 OCT 2018, 11:30 AM - 12:00 PM Central Daylight Time

Description:

This public webinar will share results from the Scoping Process in the development of a standard for 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, CDISC

Webinar Language: English

 

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Newcomers' Webinar

Date and Time:
THU, 27 SEP 2018, 10:00 AM - 11:30 AM Central Daylight Time

Description:

New to the world of CDISC Standards? This webinar, presented by some of the foremost CDISC experts, will cover the fundamentals to get you up to speed on the what, how, and why of CDISC standards.  We will address such topics as:

  • The need for global standards in the current industry environment,
  • An overview of the CDISC Model
  • Regulatory requirements
  • Use cases for CDISC Standards.

Presenter: 

  • Kit Howard, CDISC, Senior Education Expert

 

Webinar Language: English

 

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CDISC Public Webinar - Define-XML v2.1 Public Review

Date and Time
THU, 9 AUG 2018, 10:00 AM - 11:30 AM Central Daylight Time

Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC content standards, it provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM. Define-XML is required by the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for every study in each electronic submission to inform the regulators which datasets, variables, controlled terms, and other specified metadata were used.

The Define-XML team is releasing Define-XML Version 2.1 for a second public review. In the course of resolving comments during the first Public Review, which ran from March to May 2017, three significant changes were made to the standard in response to feedback received. These changes warrant a second public review and include:

1)  Updated requirements for referencing the CDISC Standards and Controlled Terminology used in a study.
2) A new attribute for indicating when a dataset or variable has no data.
3) A new SubClass element and related changes to the dataset Class definition
 
Members of the development team will  provide details about these changes and describe how they will benefit Define-XML users.

Webinar Language

English

Presenters

  • Sally Cassells, Next Step Clinical Systems, Owner/President
  • Sam Hume, CDISC, VP of Data Science
  • Marcelina Hungria, DIcore Group, Consultant/Owner
  • Lex Jansen, SAS Institute, Principal Software Developer
  • Monika Kawohl, HMS Analytical Software GmbH, Principal Statistical Programmer

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CDISC Public Webinar - Standards Updates - QRS, CGI, and PGI Supplements

Date and Time
TUE, 24 JUL 2018, 10:00 AM - 11:30 AM Central Daylight Time

This public webinar will introduce CDISC’s new process for providing public review comments for QRS Supplements as well as present supplements for Clinical Global Impressions (CGI) and Patient Global Impressions (PGI), which will be out for public review.

CDISC develops SDTM (tabulation) and ADaM (analysis) supplements that provide information on how to structure the data in a standard format for public domain and copyright-approved instruments. We also develop Controlled Terminology to be used with the supplements. An instrument is a series of questions, ratings, tasks or assessments used in clinical research to provide a qualitative or quantitative assessment of a clinical concept or task-based observation.

CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all. 
 

Webinar Language

English

Presenters

  • Steve Kopko, Subject Matter Expert, Consultant, Standards, CDISC

  • Dana Booth, Consultant, Standards, CDISC

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