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Webinars

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 - 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, CDISC/SAS, 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 Idec 
  • Sally Cassells, Owner, Next Step Clinical Systems LLC 

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

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. 

CDISC Tech Webinar Series - CDISC SHARE 2.0

WED, 16 AUG 2017 10:00 AM CDT
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Title
CDISC SHARE 2.0

Description
Join the CDISC SHARE Team for this Technology Webinar where we will discuss:

*In April 2017, CDISC carried out a Public Input period, inviting interested parties to submit comments on the CDISC SHARE 2.0 Model Schema. CDISC SHARE 2.0 represents a major upgrade of the current SHARE model and includes significant improvements, such as better separation of SEND, SDTM, and ADaM from their implementation guides, the ability to map Therapeutic Area (TA) Standards to the Foundational Standards, and a link from Controlled Terminology to their appropriate standards.

CDISC SHARE 2.0 has been designed using the W3C Resource Description Framework (RDF) and builds on the key concepts of the ISO 11179 standard for Metadata Registries (MDR).

The CDISC SHARE Team has considered Public Input provided and will relay requests, suggestions, and priorities during the webinar.

Date and Time
WED, 16 AUG 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

  • Dr. Lauren Becnel, VP, Strategy and Innovation, CDISC
  • Anthony Chow, Senior Manager, Technical Development, CDISC
  • Dr. Sam Hume, Head of Data Exchange Technologies, CDISC

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

 

CDISC Public Webinar Series - Controlled Terminology Quarterly Updates

TUE, 18 JUL 2017 10:00 AM CDT
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Title
Controlled Terminology Quarterly Updates

Description

The webinar will highlight changes to Package 30 CT, published 30 JUN 2017 and will discuss the public review period for Package 31, which runs from 23 JUN 2017 to 21 JUL 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. 

Date and Time
TUE, 18 JUL 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

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

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

CDISC Public Webinar Series - Duchenne Muscular Dystrophy TA Public Review

THU, 1 JUN 2017 10:00 AM CDT
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The CDISC Public Webinar Series - Duchenne TA User Guide is intended for all individuals interested in learning more about CDISC Standards. 

Title
Duchenne Muscular Dystrophy TA Public Review

Description
The purpose of this TAUG-DMD is to describe how to use CDISC standards to represent data pertaining to Duchenne Muscular Dystrophy studies. This first version (v1.0) focuses on the representation of data using the Study Data Tabulation Model (SDTM). Types of data covered include genetics and results from a variety of disease assessments including cardiac, musculoskeletal, and pulmonary function assessments as well as imaging data. Data standards are also being developed for a variety of functional tests.  Analyses will not be covered in depth as there are not many clearly defined analyses for DMD at this time.

Date and Time
THU, 1 JUN 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

  • Bess LeRoy, Metadata Engineer, CDISC
  • Diane Corey, Data Manager, C-Path 
  • Jon Neville, Program Director, Data Standards and Management, C-Path 
  • Emily Hartley, Data Manager, C-Path 

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

 

CDISC Public Webinar Series - Colorectal Cancer TA User Guide Public Review

TUE, 30 MAY 2017 10:00 AM CDT
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The CDISC Public Webinar Series  is intended for all individuals interested in learning more about CDISC Standards. 

Title
Colorectal Cancer TA User Guide Public Review 

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

Webinar Language
English

Panelists

  • John Owen, Project Manager, CDISC 
  • Melanie Paules, Manager Data Standards, GSK
  • Elizabeth Langevin 
  • Marie-Laurence Harle-Yge, Clinical Scientist, Hoffmann La Roche
  • Barbara Leutgeb, Medical Leader, Roche Pharmaceuticals
  • Kathleen Mellars, Data Standards/Operational Fellow, Novartis
  • Erin Muhlbradt, Clinical/Biomedical Information Specialist, MSC
  • Ellen J. Schatz 
  • Joyce Hernandez, Manager of Clinical Data Standards, Eliassen Group

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

 

CDISC Tech Webinar Series - Pattern Based Metadata Repository: A New Approach to Improve the Efficiency and Quality of Data Standards

THU, 25 MAY 2017 10:00 AM CDT
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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. 

Title
Pattern-Based Metadata Repository: A New Approach to Improve the Efficiency and Quality of Data Standards

Description
This webinar will examine the management of relationships, and mapping between, CDASH, SDTM and ADaM data standards through the use of concept-linked patterns and reusable templates. Implementation of this pattern-based hub and spoke approach in the Metadata Repository leads to consistency, increased quality and increased efficiency from database design to reporting and analysis. 

Date and Time
THU, 25 MAY 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

  • Julius Kusserow, Head of Data Standards, PAREXEL Julius Kusserow is Head of PAREXEL Data Standards based in Berlin, has 15 years industry experience within data management, biostatistics and statistical programming and has been working with CDISC standards for the last 10 years.  Julius is PAREXEL’s representative to the CDISC Advisory Council. The last 3 years he has been involved in the in a collaboration to develop the PAREXEL MDR.
  • Alan Cantrell, Senior Manager, Clinical Database and Statistical Programming, PAREXEL Alan Cantrell is a senior manager within statistical programming at PAREXEL based in Sheffield, has 16 years industry experience within data management, database programming and statistical programming and started working with CDISC standards 11 years ago.  Working at a CRO has provided an opportunity to work with a number of different standards and client expectations which has in turn sparked a keen interest in data standards and improving the way that the industry approach submission.
  • Deb Copeland, Principal Data Standards Analyst, Data Operations Administration, PAREXEL Deb Copeland is a Principal Data Standards Analyst within the PAREXEL Data Standards team and based in Durham North Carolina.  Deb has 22 years pharmaceutical industry experience in data management, Laboratory data standards, Central Lab vendor management, and 6 years in data standards governance and implementation.  The last two years she has been immersed in a collaboration to develop the PAREXEL MDR, a new and innovative system to implement end to end CDISC standards.
  • Sam Hume, Head of Data Exchange Technologies, CDISC

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

 

CDISC Technology Webinar Series - SHARE 2.0 Upcoming Release & Demo

20 APR 2017

8:30 AM - 11:00 AM CDT

Click here to register

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

 

20 APR 2017

8:30 AM - 11:00 AM CDT

Agenda

The webinar will discuss the forthcoming SHARE 2.0 release, which will include, for the first time, full support for Therapeutic Area standards, biomedical concepts, terminology subsets, rules and other key enhancements. The webinar will include a demonstration of a Resource Description Framework (RDF) representation of standards content in SHARE 2.0.

Panelists

  • Dr. Lauren Becnel, VP of Biomedical Informatics & Alliances, CDISC 
  • Frederik Malfait, Owner, IMOS Consulting 
     

Click here to register

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

CDISC Public Webinar Series - Controlled Terminology Quarterly Updates

04 APR 2017

10:00-11:30 AM CST

Click here to register 

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

CDISC invites you to attend public review for Controlled Terminology. Click here to register. We rely 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. 

Agenda: 

 
Panelist(s): 
  • Erin Muhlbradt, CDISC Project Lead, NCI EVS 
  • Chris Gemma, Project Manager, CDISC 

CDISC Public Webinar - BRIDG 5.0 Public Review

29 MAR 2017

10:00-11:30 AM CST

Click here to register 

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

Description
BRIDG 5.0 Public Review

BRIDG (ISO:14199) is an international standard biomedical research domain information model developed by stakeholders including CDISC, the National Cancer Institute, the FDA, Health Level 7 (HL7), and International Standards Organization (ISO). This most recent release includes medical imaging, improved concepts for international clinical trial conduct and oncology views based on CDISC Therapeutic Area Standards.  

Panelists

  • Edward Helton, Associate Director of Clinical Trails Programs and Products, NIH, NCI/CBIIT 
  • Wendy VerHoef, Senior Systems Analyst, Samvit Solutions
  • Michael Glickman, President, Computer Network Architects 
  • Lauren Becnel, Vice President of Biomedical Informatics and Alliances Informatics and Alliances, CDISC

CDISC Members Only Mini-Training Series - Governance for Data Capture Standards

THU, 17 AUG 2017 10:00 AM CDT
REGISTER NOW

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
Governance for Data Capture Standards

Description
Good governance is critical for ensuring consistent and “fit-for-use” data. Data governance standards should begin with the data capture environment and designing well-defined elements. While some aspects will be customized to a company, many are general and apply across organizations. Join CDASH experts to explore considerations and best practices in data capture standards governance.

Date and Time
THU, 17 AUG 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists

  • Gary Walker, Associate Director, Quintiles 
  • Michael Ward, Data Standards Consultant, Eli Lilly 
  • Melissa Binz, Business Process Owner - Study Data Management, Pfizer 
  • Judy Tran, Manager, Medidata Solutions 
  • Trisha D. Simpson, Director, Global Biometry Standards, UCB Pharma

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

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.