Learn from standards experts during our monthly webinars.

 

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

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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CDISC Public Webinar Series - Standards Updates and Additions - Controlled Terminology Quarterly Updates - Q3 2018

THU, 5 JUL 2018 11:30 AM CST
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Join the Controlled Terminology team for our quarterly webinar, which will highlight changes to Controlled Terminology Package 34 and discuss Public Review for Package 35, which runs until 20 July 2018.

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.

Agenda:
- Controlled Terminology, Package 34 Publication
- Controlled Terminology, Package 35 Public Review

Date and Time

Thursday, 5 July 2018

11:30 AM - 12:30 PM CDT

Panelists

  • Erin Muhlbradt, CDISC Project Lead, NCI EVS
  • Chris Gemma, Project Manager, CDISC

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CDISC Members-Only Mini-Training Series - ODM v2 Overview

Date and Time:
THU, 25 OCT 2018, 10:00 AM - 11:30 AM Central Daylight Time

Description:

ODMv2 represents a significant step toward modernizing the CDISC Data Exchange Standards to spark more efficient methods of data exchange throughout the clinical research data lifecycle. This presentation will discuss the vision and drivers motivating the advances in ODMv2. The CDISC Data Exchange Standards play a major role in supporting standards-based automation and the planned advances in these standards increase the opportunities to develop new, innovative software tools based on these standards.

ODM-XML v1.3.2 is the most current version of the standard. A number of CDISC standards have been developed by extending ODM-XML including:  Define-XML, SDM-XML, Dataset-XML, CTR-XML and CT-XML. ODM-XML provides a common base structure for these standard extensions easing the learning curve and implementation complexity.

Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org

Note: Please use your corporate e-mail address to register for this webinar. This is to confirm your CDISC membership.Confirmations will be sent out within a few days after your completed registration. 

Presenter

  • Sam Hume, DSc., VP, Data Science, CDISC

Webinar Language: English

 

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CDISC Public Webinar Series - Standards Updates and Additions - HIV TAUG v1.0 Public Review

TUE, 12 JUN 2018 10:00 AM - 11:30 AM CDT
REGISTER NOW

Description

CDISC invites you to attend the Public Review webinar for Version 1.0 of the HIV Therapeutic Area User Guide (TAUG-HIV). TAUG-HIV v1.0 was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to studies for the treatment and prevention of HIV and the necessary metadata to represent such concepts consistently with the CDISC standards, such as CDASHSDTM and ADaM.

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 quality and processes for the benefit of all.

To view the user guide: TAUG-HIV v1

Topics included in this TAUG include:

  • Diagnosis of HIV
  • Risk Factors and Mode of Transmission
  • Menstrual History and Pelvic Examinations
  • Mother-Infant Pairs in HIV Studies
  • HIV Treatment with Oral Antiretroviral Therapy (ART)
  • Pre-Exposure Prophylaxis (PrEP)
  • CD4 Counts, Viral Detection, and Viral Load
  • Drug Susceptibility including phenotypic drug sensitivity and genetic resistance calculators
  • Several Analysis concepts including the FDA snapshot analysis and pregnancy outcome analysis

Date and Time
TUE, 12 JUN 2018
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

  • Amy Palmer, Director, Standards Development, CDISC
  • Laura Butte, Project Manager, Data Standards, Critical Path Institute
  • Nate Freimark, Vice President, Clinical Programming and Data Standards, The Griesser Group
  • Bess Leroy, Metadata Engineer, CDISC
  • Jon Neville, Metadata Engineer, CDISC
  • Diane Wold, Sr. Director, Standards Development and Modeling, CDISC

CDISC Public China Webinar - CDASH v2.0

Date and Time
FRI, 22 JUN 2018 10:00 AM - 11:00 AM BEIJING TIME

Description

This webinar will be presented in Mandarin.

The CDISC Foundational Standard for data collection, CDASH, establishes a standard way to collect data across studies and sponsors so that formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.  This webinar will address CDASH v2.0, which comprises the CDASH Implementation Guide  v2.0, the CDASH Model v1.0, and CDASHIG metadata tables to define basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms.

Webinar Agenda:

  • CDASH v2.0 简介 (CDASH v2.0 Overview)
  • CDASH标准介绍 (CDASH Standards Introduction)
  • CDASH IG v2.0主要变化 (CDASH IG v2.0 Main Updates)
  • CDASH Metadata 和CDASH Model 介绍(CDASH Metadata and CDASH Model introduction)

Webinar Language
Mandarin

Presenters

  • Lily Zhao, Director, Data Management, PAREXEL
  • John Wang, Associate Director of Statistical Analysis, dMed Global

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CDISC Public Webinar - CDISC Newcomers Informational Webinar

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.

Date and Time
THU, 28 JUN 2018
8:00 AM - 9:30 AM CDT // 3:00 PM - 4:30 PM Central European Time

Webinar Language
English

Presenter

  • Peter Van Reusel, Chief Standards Officer, CDISC

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