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 Series - Standards Governance Challenges

Date and Time
THU, 8 MAR 2018 -10:00 AM - 11:30 AM CDT

Description
Having a data standards governance strategy is important for the successful development and end-to-end implementation of data standards across the clinical development life cycle. The standards governance framework provides a visible platform for discussions and decision-making, takes into account the needs of all the stakeholders across the enterprise, ensures standard activities are adequately resourced and supported, as well as promotes a unified approach and interpretation of regulatory and standard model requirements.

Learn best practices as well as challenges in standards governance, and how to address them. We will also discuss developing a plan to deal with updates to standards. As standards governance evolves over time, learn how to meet your changing organizational and business needs. 

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.

Webinar Language
English

Panelists

  • Diane Piper, Head of Clinical Information Management, Shire
  • Melissa Cook, Protocol Entities Team Co-Lead (Volunteer), CDISC
  • A. Brooke Hinkson, Head of Global Clinical Data Standards, Merck

 

CDISC Public Webinar Series - CDISC Newcomers Webinar

THU, 8 FEB 2018 10:00 AM - 11:30 AM CET (6:00 AM - 7:30 AM CST)
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Description

Back by popular demand to accommodate attendees in Europe.

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 8 FEB 2018
10:00 AM - 11:30 AM Central European Time (6:00 AM - 7:30 AM Central Standard Time)

Webinar Language
English

Presenter

  • Peter Van Reusel, EU Liason, CDISC
  • Shannon Labout, Interim Chief Standards Officer, CDISC

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CDISC Public Webinar Series - Standards Updates and Additions - ADaM IG v1.2 Public Review

TUE, 23 JAN 2018 10:00 AM CST
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Title

ADaM IG v1.2 Public Review Webinar

Description

This webinar will discuss the Public Review for version 1.2 of ADaM Implementation Guide (IG) and introduce changes and updates expected in this new version. 

The ADaMIG specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to implementation issues.

Significant updates included:

  • New Permissible variable within BDS: PARQUAL
  • Nomenclature for Stratification variables within ADSL
  • Recommended approach for bi-directional toxicity grades

Public review is a key quality step in the development of a standard. 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. 

Date and Time
TUE  23 JAN 2018
10:00 AM - 11:30 AM CT

Webinar Language
English

Panelists

  • Brian Harris, Director, Clinical Data Analysis & Reporting Excellence, MedImmune
  • Terek Peterson, Senior Director, Global Statistical Standards,Chiltern

CDISC Public Webinar Series - Controlled Terminology Quarterly Updates Q4 2017

THU, 11 Jan 2018 10:00 AM CST
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The webinar will highlight changes to Package 32 CT and discuss public review for Package 33, which runs until 19 JAN 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, Batch 32 Publication
- Controlled Terminology, Batch 33 Public Review

Date and Time

Thursday, 11 January 2018

10AM-11AM CST

Panelists

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

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CDISC Public Webinar Series - CDISC Newcomers Webinar

THU, 18 JAN 2018 10:00 AM - 11:30 AM CDT
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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 18 JAN 2018
10:00 AM - 11:30 AM CDT

Webinar Language
English

Presenter

  • Peter Van Reusel, EU Liason, CDISC
  • Shannon Labout, Interim Chief Standards Officer, CDISC

Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by Citrix).

CDISC Mini-Training Series - Categorization of Data in ADaM

TUE, 28 NOV 2017 10:30 AM - 11:30 AM CDT
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Title
Categorization of Data in ADaM

Description

The CDISC Foundational Standard for analysis, ADaM, features variables that allow you to cluster, group, or categorize information for analysis purposes. Sometimes it may not be entirely clear which variable should be used and when. This webinar will review the need for data categorization and display the various ADaM categorization methods and variables. We will examine case studies, provide ADaM categorization strategies, and discuss when more than one technique will work for a given analysis situation.

Audience: CDISC programmers and statisticians with basic exposure to the CDISC ADaM model. 

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.

Date and Time
TUE, 28 NOV 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Presenter

  • Jack Shostak, Associate Director, Statistics, Duke Clinical Research Institute

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CDISC Members Only Mini Training - Ahead of the Curve: Leading with Industry Data Requirements

THU, 25 JAN 2018 10:00 AM - 11:30 AM CDT
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Title

 Ahead of the Curve: Leading with Industry Data Requirements

Description

Staying ahead of the curve of global regulatory requirements can be challenging. This webinar will review the current landscape of requirements with particular focus on clinical data requirements. Attendees will learn recent developments in requirements, best practices for managing and implementing requirements in your organization, and the importance of an organized, cross-functional approach to managing and embedding the requirements within a pharmaceutical company or CRO.  

Audience: Programmers of all levels, including lead programmers and managers.

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.

Date and Time
THU, 25 JAN 2018
10:00 AM - 11:30 AM CT

Webinar Language
English

Panelists

  • Maria Dalton, Director of Programming, GSK
  • Nancy Haeusser, GSK
  • Warwick Benger, Standards and Efficiency Head, GSK

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CDISC Public Webinar Series - Standards Updates and Additions - SDTM v1.7 Public Review

TUE, 31 OCT 2017 10:00 AM - 11:30 AM CDT
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Title

SDTM v1.7 Public Review Introductory Webinar

Description

This presentation will serve as an introduction to the changes and updates to SDTM v1.7 that can be expected in the new version, as well as an introduction to the public review period.

SDTM v1.7 supports SDTM Implementation Guide (IG) v3.3 and SDTMIG-Medical Devices (MD) v1.1; SDTM v1.6 supports the Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.1. Drafts of SDTMIG v3.3 and SDTM v1.6 have been included in the review package for reference only, not for additional comment.

Public review is a key quality step in the development of a standard. 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. A link to more information regarding the public review can be found here.

Date and Time
TUE  31 OCT 2017 
10:00 AM - 11:30 AM CT

Webinar Language
English

Panelists

  • Diane Wold, Senior Director, Standards Development and Modeling, CDISC
  • Bess LeRoy, Metadata Engineer, CDISC
  • Janet Reich, Clinical Data Standards Lead, Applied Clinical Intelligence
  • Carey Smoak, Senior Consultant, Dataceutics

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CDISC Tech Webinar Series

THU, 26 OCT 2017 10:00 AM - 11:30 AM CDT
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Title

Leveraging CDISC Standards to Drive Cross-trial Analytics; Graph Technology

Description

The CDISC Technology Webinar Series is intended for all individuals interested in learning more about how CDISC Standards are leveraged in new and emerging technologies. 

CDISC standards based trials are well defined for individual trial analysis. However, analyses across multiple trials, e.g., meta-analysis, can be difficult due to different data parameters being used for each trial. Different data parameters can be harmonized and conformed using the framework of CDISC standards.

Graph technology uses graph structures to represent and store data. This presentation will provide an overview of a tool set based on graph and semantic technologies designed to enhance and improve current processes and impact analysis. 

Date and Time
THU, 26 OCT 2017 
10:00 AM - 11:30 AM CT

Webinar Language
English

Panelists

  • Jim LaPointe, Managing Director, Life Sciences & Healthcare, Cambridge Semantics
  • Patrick Jackson, Senior Solutions Engineer, Cambridge Semantics
  • Kirsten LangenDorf, Subject Matter Expert, A3 Informatics
  • Dave Iberson-Hurst, Director, A3 Informatics
  • Lauren Becnel, VP, Strategy and Innovation, CDISC

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CDISC Public Webinar - PTSD Therapeutic Area User Guide Public Review

TUE, 26 SEP 2017 10:00 AM CDT
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Version 1.0 of the Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) describes the most common biomedical concepts relevant to studies to treat PTSD and the necessary metadata to represent such consistently with CDISC standards, such as CDASH, SDTM, and ADaM. TAUG-PTSD v1.0 was funded by Cohen Veterans Bioscience and developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative and the CDISC Standards Development Process.

TAUGs extend the Foundational Standards to represent data that pertains to specific disease areas and include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions.

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.

Panelists

  • Dana Booth, Clinical Trials Data Standards Development Consultant, CDISC
  • Allyson Gage, Chief Medical Officer, Cohen Veterans Bioscience
  • Kathy Mellars, CDASH Consultant
  • Amy Palmer, Director, Standards Development, CDISC

Date and Time
TUE, 26 SEP 2017 
10:00 AM - 11:00 AM CDT

Webinar Language
English

 

Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by Citrix).