Learn from standards experts during our monthly webinars.

 

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

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

 

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CDISC Public Webinar Series - Controlled Terminology Quarterly Updates, Q3 2017

TUE, 3 OCT 2017 10:00 AM CDT
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The webinar will highlight changes to Package 31 CT, and will discuss the public review period for Package 32, which runs until 13 OCT 2017.

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 31 Publication
- Controlled Terminology, Batch 32 Public Review

Date and Time

Tuesday, 3 October 2017

10AM-11AM CST

Panelists

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

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CDISC Public Webinar - Japanese SDTMIG v 3.2 Public Review and JIRA Demonstration

FRI, 15 SEP 2017 10:00 AM JST
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Title

CDISC Public Webinar - Japanese SDTMIG v 3.2 Public Review and JIRA Demonstration

Description

CDISC and the Japan CDISC Coordinating Committee (J3C) are pleased to announce the beginning of a public review period for the Japanese translation of the SDTM Implementation Guide v3.2 (SDTMIG v3.2). The draft translation of the “first batch” (content from Section 1 "Introduction" through Section 4 "Assumptions for Domain Models" of SDTMIG v3.2) will be made available for public comment in a few days. CDISC and the J3C encourage those using this standard in Japan to participate in this public review in order to contribute to the improvement and quality of the translation.

During this public webinar, official panelists from the Japan CDISC Coordinating Committee (J3C) will present the collaborative work of The Nagoya Medical Center, Translational Research Informatics Center (TRI) and CDISC Japan User Group (CJUG) SDTM Team who translated the SDTMIG v3.2 into Japanese. They will also demonstrate and explain the public review process, including the use of JIRA to provide comments on the translation.

Date and Time
FRI, 15 SEP 2017 
10:00 AM - 10:30 AM JST

Webinar Language
Japanese

Panelists:

  • Representatives from Japan CDISC Coordinating Committe - To Be Announced

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CDISC Public Webinar - Huntington's Disease Therapeutic Area User Guide Public Review

TUE, 12 SEP 2017 10:00 AM CDT
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Title

CDISC Public Webinar - Huntingtons Disease Therapeutic Area User Guide v1.0 Public Review

Description

Therapeutic Area User Guides (TAUG) extend the Foundational Standards to represent data that pertains to specific disease areas. TAUGs 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.

Version 1.0 of Huntington's Disease Therapeutic Area User Guide (HD-TAUG) describes the most common biomedical concepts relevant to HD studies and the necessary metadata to represent such data consistently, allowing datasets from multiple sources to be compared or combined for analysis. HD-TAUG v1.0 focuses on the representation of data using the Study Data Tabulation Model (SDTM). Types of data covered include family history, genetics, and biomarkers for assessing disease onset and progression. Specific biomarkers include neuroimaging assessments (MRI and PET) and biofluid biomarkers, with a focus on cerebrospinal fluid.

Date and Time
TUE, 12 SEP 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists:

  • Jon Neville, Metadata Engineer, Standards Development, CDISC
  • Daniel Olson, Clinical Data Programmer, C-Path

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CDISC Public Webinar Series - CDISC Evolution

WED, 16 AUG 2017 10:00 AM CDT
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CDISC Evolution

WED, 16 AUG 2017 10:00 AM - 10:30 AM CDT

In response to ongoing feedback from our stakeholder community, CDISC is evolving with new and updated procedures and processes in an effort to deliver more transparency, accountability, and predictability. We invite you to join us to learn about these changes.

  • New Annual Release Schedule
  • Updated Standards Development Procedure (COP-001)
    • early cross-team governance
    • escalation policy
    • defines status of standards
  • New Volunteer Engagement Procedure (COP-019)
    • describes process for on-boarding volunteers
    • creates a consistent team leadership structure and succession plan
    • sets expectations for respectful and productive volunteer participation
  • Volunteer Training and Hours Tracking

Date and Time
WED, 16 AUG 2017 
10:00 AM - 10:30 AM CDT

Webinar Language
English

Panelists

  • Shannon Labout, Interim Chief Standards Officer, CDISC
  • Dr. Lauren Becnel, VP, Strategy and Innovation, CDISC
  • Rhonda Facile, VP, Standards Development, CDISC

CDISC Members Only Mini-Training Series - Define-XML v2.0 Completion Guidelines & Style Sheet Recommendations

THU, 28 SEP 2017 10:00 AM CDT
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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.

Title

CDISC Members Only Mini-Training Series - Define-XML v2.0 Completion Guidelines and Style Sheet Recommendations

Description

Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the regulatory authorities what datasets, variables, controlled terms, and other specified metadata were used.

Define-XML is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.   

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page

Date and Time
THU, 28 SEP 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists:

  • Marcelina Hungria, Data Submission Consulting Services, Dlcore Group, LLC 
  • Dmitry Kolosov, Principal Statistical Programmer, PAREXEL 
  • Lex Jansen, Principal Software Developer, SAS Institute Inc. 
  • Prafulla Girase, Principal Analyst, Biogen
  • Sally Cassells, Owner, Next Step Clinical Systems LLC 

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Please register for this members only webinar using your organizational e-mail address. If you aren't sure whether your organization is a CDISC Member, please review the member list here and confirm before you register.