Upcoming Webinars

Webinars address industry hot topics, best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts.
For more information about CDISC webinars, please fill out our contact form here.

PLEASE NOTE: All listed webinars are in US Eastern time, unless otherwise indicated. 


Join us for our quarterly Controlled Terminology updates. This quarter, we will be covering:

  • P58 Public Review – includes all the usual content plus TMF, CDASH SOGI, CDMH, Glossary, and MRCT
  • CT Basics –> CDISC CT Maintenance - how to submit a change request and best practices for the submission of change requests

Presenter(s)

Dr. Erin Muhlbradt, NCI-EVS (Contractor)
Dr Jordan Li, NCI-EVS (Contractor)

Language

English


Join CDISC and Open-Source Developer for the COSA Quarterly Spotlight!

Register to hear from open-source developers in the CDISC community as they showcase their free tools as part of the CDISC Open Source Alliance (COSA). Join us to hear presentations on:

  • {sdtm.oak} v0.1 Release
  • CORE: Authoring & Running Your Own Rules
  • CORE: Checking USDM for Conformance

{sdtm.oak} v0.1 Release

Ganapathy

Rammprasad (Ram) Ganapathy from Roche/Genentech will present on an EDC and standards-agnostic solution that enables a modular approach to programming SDTM in R.

Ganapathy is a Principal Data Scientist at Roche/Genentech with over 15 years of experience in EDC and statistical programming.

He leads the OAK team and is also the product owner of OAK. He and his team developed R based SDTM automation solution OAK from proof of concept to full implementation, and now OAK is used for SDTM creation across all studies at Roche. Ram is also the Product Owner for the open-source {sdtm.oak}.


CORE: Authoring & Running Your Own Rules

RadelickiThe CORE project encourages the use of its open-source software to test study data for conformance to various standards by using the same set of unambiguous rules governed by CDISC. Next to these rules, establishing an industry-standard method for rule creation offers a promising prospect.

Roman Radelicki will explore creating custom rules using the Conformance Rule Authoring tool. Our journey/challenges of implementing the authoring tool and running custom rules with the CORE-engine, will be shared.

Radelicki started his career as Programmer in 2006 and joined SGS in 2009. During his career at SGS he held several positions and became Head Data Technology in 2021. He is mainly responsible for managing the data engineering, data programming and data science teams, providing support to the different departments. Roman is BSc in Computer Science and also in Multimedia Design.


CORE: Checking USDM for Conformance

Snoeijer DDF rule shave been developed based on the Unified Study Definition Model (USDM) requirements. Berber Snoeijer's presentation will cover the development of CORE DDF rules in the Proof of Concept phase which has been finalized, along with the plans for the next phase to align with version 3.0 and 4.0 of the USDM.

Snoeijer will also cover the corresponding required changes to the CORE engine and rule editor to enable checking of the API json file and specific USDM requirements. 

Snoeijer is the USDM development team lead at CDISC and was involved in the proof of concept phase for the CORE DDF rules. She has a background in biomedical sciences and programming and more than 25 years of experience in the industry in data analysis, data flow optimization, and software development. 


Presenter(s)

Language

English


Join CDISC for an informative webinar to hear from CDISC Oncology SDS team and gain valuable insights on the following: 

  • CDISC Oncology Disease Response Supplements:Learn about the development of Oncology Terminology and Disease Response Supplements which provide a mechanism to represent criteria specific examples.
  • Oncology Biomedical Concepts:Find out more about Oncology Biomedical Concepts and the SDTM Dataset Specializations for RECIST 1.1 Disease Response Criteria including a demo and some practical use cases.
  • Future Plans Including CDISC Biomedical Concepts:Hear about the CDISC Oncology SDS Team's future plans.

Presenter(s)

Melanie Paules, Director Statistical Programming, Takeda
Ryan Dempsey, Associate Director Data Standards, GlaxoSmithKline
Erin Muhlbradt, Clinical/Biomedical Information Specialist & CDISC Terminology Program Lead, US NCI-EVS
Linda Lander, Director Data Science and Product Owner CDISC Biomedical Concepts, CDISC
Lex Jansen, Senior Director Data Science, CDISC

Language

English


USDM/DDF logo After the successful release of USDM v3.0 in April 2024, CDISC continues the collaboration with TransCelerate’s Digital Data Flow Project into Phase 4. This phase will focus on further enhancement to the Unified Study Definition (USDM) reference architecture, which will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards. 

The focus areas of DDF Phase 4 are:

  • USDM Enhancements ​including further IDMP Alignment, refinement of amendments and versions to align with ICH-M11, complex studies designs such as multiphase seamless designs, additional trial registration mappings, and statistical/estimands enhancements​
  • Continued alignment of USDM with the emerging ICH M11​ template and technical specification
  • Participation in the Utilizing the Digital Protocol (UDP) project with TransCelerate, ICH and HL7 Vulcan​
  • Continued development of USDM Conformance Rules to support USDM v3.0 and v4.0​
  • Continued support and development of test data and test tools​
  • Development of training and education materials in conjunction with TransCelerate’s Change and Engagement team to foster adoption of DDF​
  • Alignment on study design elements with CDISC's Trial Master File (TMF) reference model​

Join us for this informational webinar to learn about the release of Phase 3 and additional details on Phase 4 of this exciting project.


Presenter(s)

John Owen, CDISC
Dave Iberson-Hurst, CDISC
Berber Snoeijer, CDISC
Bill Illis, DDF Workstream Initiative Lead

Language

English


Join CDISC for a comprehensive webinar exploring your diverse training pathways! 

In this webinar, you'll gain valuable insights into CDISC's training programs, catering to all experience levels and learning preferences:

  • NEW Hands-on Implementation Trainings: Discover new opportunities for hands-on implementation training in 2024.
  • IACET Certification: Understand the value of industry-recognized credentials for your professional development.
  • CDISC Learning Management System: Witness a firsthand demonstration of CDISC's Learning Management System (LMS).
  • Trial Master File (TMF) Training Updates: Receive a dedicated presentation from CDISC-authorized TMF instructors.
  • Customized Private Trainings:Discover how your organization can benefit from customized training options tailored to your specific needs.
  • Upcoming Public Trainings: Explore upcoming instructor-led trainings covering the fundamentals and advanced concepts of CDISC standards.

Presenter(s)

John Ezzell, Head of Education, CDISC
Morgan Dancy, Sr. Manager of Education, CDISC
Mackenzie Voots, Manager of Education, CDISC
Dawn Niccum, Executive Vice President, QA & Compliance, inSeption Group
Lisa Mulcahy, Owner, Mulcahy Consulting

Language

English


Join us for our quarterly TMF Reference Model Initiative General Meeting where we will provide an update on the CDISC transition and look at the latest regulations and initiatives that affect TMFs.


Presenter(s)

Language

English


Join open-source developers from the CDISC community as they showcase their free tools as part of the CDISC Open Source Alliance (COSA). Learn how you can leverage these tools to facilitate the implementation of CDISC standards in your systems. Stay tuned for more specific details about what the team will cover in this spotlight!


Presenter(s)

Language

English


Join us for our quarterly TMF Reference Model Initiative General Meeting where we will provide an update on the CDISC transition and look at the latest regulations and initiatives that affect TMFs.


Presenter(s)

Language

English


Join open-source developers from the CDISC community as they showcase their free tools as part of the CDISC Open Source Alliance (COSA). Learn how you can leverage these tools to facilitate the implementation of CDISC standards in your systems. Stay tuned for more specific details about what the team will cover in this spotlight!


Presenter(s)

Language

English