Upcoming Webinars

Large trials generate many analysis results in the form of tables, figures, and written reports, yet these results are rarely output in a form that is machine-readable. Additionally, there is no standard way of describing and organizing these results, making it difficult to automate their generation, make them reproducible, trace their origin or enable them to be reused in other outputs.

To address these inefficiencies, CDISC is developing the Analysis Results Standards (ARS), which aim to facilitate automation, reproducibility, reusability, and traceability of analysis results data.

Join CDISC as we share progress, key objectives and project deliverables regarding the development of ARS.

Presenter(s)

Bess LeRoy, Head of Standards Innovation, CDISC
Bhavin Busa, ClymbClinical
Richard Marshall, Accurate Systems

Language

English

The scope for the Immunogenicity Specimen Assessments (IS) domain has been expanded in the SDTMIG v3.4. It is now designed to map data pertaining to specimen-based assessments that measure the “presence, magnitude and scale of the immune response upon any antigen stimulation or encounter.” This expands the scope of the IS domain from the previous versions of SDTMIG (v3.2/v3.3), where the IS domain was defined to represent data pertaining to “assessments that describe whether a therapy provoked/caused/induced an immune response”.

This change in the IS domain scope for the SDTMIG v3.4 has impact on both lab (LB) and microbiology (MB) domain scope and data mapping, as well as the development and maintenance of controlled terminology for all three domains.

Join us for a webinar where we will discuss:

• A history and the rationales behind the IS domain scope update for the SDTMIG v3.4.
• A brief walkthrough of the IS domain new standard variables and high-level modeling guiding principles.
• Its impact on the LB and MB domain scopes.
• Its impact on controlled terminology in LB, MB and IS.
• A summary of planned future directions for refinements to IS and development of materials to support stakeholder implementation over time.

Presenter(s)

Dr. Jordan Li, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Language

English

Join open-source developers from the CDISC community and the COSA team as they share upcoming projects and showcase free tools. 

Agenda:

• Dataset-JSON as an Alternative Transport Format for Regulatory Submissions Pilot: CDISC, PHUSE, FDA, and industry participants plan to pilot a new CDISC dataset exchange standard, Dataset-JSON, to evaluate its possible future use in regulatory submissions.
• The SAS Open Clinical Standards Toolkit (OpenCST): A framework that allows registration of CDISC standards metadata to enable automation, such as working in SAS with XML-based standards (Define-XML, ODM,) and validation of clinical data. Originally developed by SAS, it is now available as an open-source resource. 
• Intro to the ARS Hackathon: A sneak peek of the upcoming ARS Hackathon. The Hackathon will be an opportunity to unleash your creativity and collaborate with the CDISC community to create open-source tools that will enhance the interoperability and reusability of analysis results data and promote innovation in the industry. 

Presenter(s)

Sam Hume, VP, Data Science, CDISC
Lex Jansen, Senior Director, Data Science Development, CDISC
Bhavin Busa, ClymbClinical

Language

English

This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.

Presenter(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

Language

English

Join us for QRS Office Hours, an open forum to ask our QRS Team questions about the development and implementation of QRS Supplements and Terminology. Examples include:

• Please explain the organization of the Controlled Terminology and Questionnaires, Ratings, and Scales pages on the CDISC website?
• What are the rules for determining if a supplement should be in the Disease Response and Clin Classification (RS) domain?
• What are our QRS naming rules for terminology?
• How do we determine FACT/FACIT synonyms and terminology?
• What is the status of representing logically skipped items in QRS?

All CDISC webinars are recorded and will be posted to the Members Only Webinar Archive within a few days of the webinar's completion. 

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.

Presenter(s)

Language

English

This webinar will include a description of updated publications, including changes that occurred post-public review, and any relevant public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.

Presenter(s)

Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute

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