Learn from standards experts during our monthly webinars.

 

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

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. 

CDISC Technology Webinar Series - SHARE 2.0 Upcoming Release & Demo

20 APR 2017

8:30 AM - 11:00 AM CDT

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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

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CDISC Public Webinar Series - Controlled Terminology Quarterly Updates

04 APR 2017

10:00-11:30 AM CST

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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

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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, 24 AUG 2017 12:30PM 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
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, 24 AUG 2017 
12:30 PM - 2:00 PM 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. 

 

 

CDISC Members Only Mini-Training Series - Considerations in Submitting Non-Standard Variables

6 APR 2017

10:00-11:30 AM CST

Click here to register 

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. Thank you.

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

Agenda

Considerations in Submitting Non-Standard Variables. The SDTM Implementation Guide IG (SDTMIG) provides a standard mechanism and structure for submitting non-standard variables. With the advent and growing knowledge and use of the Findings About (FA) domain, many sponsors are challenged in determining where non-standard data best fit. In this webinar, attendees will learn several criteria that can be used to determine how best to represent such non-standard data. Click here to register 

Panelist

  • Fred Wood, Ph.D., Senior Manager and Lead, The Data Standards Consulting Group, Accenture
  • Jerry Salyers, Senior Consultant, Accenture
  • Kristin Kelly, Associate Director, Global Clinical Data Standards (GCDS), Merck