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 CDISC and Open-Source Developers from our Community for our quarterly COSA webinar
{admiral} Hackathon Readout
Learn the results from last month’s {admiral} Hackathon. The purpose of ADaM in R Asset Library {admiral} is to provide an open source, modularized toolbox that enables the pharmaceutical programming community to develop ADaM datasets in R. We’ll share lessons learned, outcomes, and upshots about developing open-source R packages for clinical reporting purposes.
OAK - SDTM Automation: Call for Participants
OAK-SDTM Automation is a new initiative to develop an open-source, metadata-driven SDTM automation solution that enables users to automate SDTM datasets in R. We’ll provide project overview (including vision and scope), describe the high-level roadmap, and show how you can volunteer to participate in this exciting project.
COSA Biomedical Concept & OpenStudyBuilder Workshop
Get a sneak peek into to our upcoming workshop that will take place at the CDISC Europe Interchange in Copenhagen.
The workshop will dive into what Biomedical Concepts (BC) are, and how they can be applied within a MDR data standards repository and a SDR study definitions repository – illustrated within the OpenStudyBuilder (OSB) solution.
Presenter(s)
Language
English
Ask panelists your questions about the SDTM Genomics Findings (GF) Domain, which is a new domain from the latest release of SDTMIG, version 3.4 . GF contains data related to the structure, function, evolution, mapping, and editing of subject and non-host organism genomic material of interest.
This webinar is a follow up to the recent Introduction to the SDTM Genomics Findings (GF) Domain (CDISC Members Only access). The panelists will respond to the questions they weren’t able to and answer new questions as well.
There is a space on the webinar registration page to submit your questions in advance so that our panelists can prepare responses. Panelists will also receive questions during the webinar.
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)
Christine Connolly, Senior Project Manager, Standards Development, CDISC
Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
Jon Neville, Senior Standards Developer, CDISC
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
CDISC, in the continued collaboration with TransCelerate’s Digital Data Flow Project , has updated 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.
Join us for the Public Review webinar for phase 2 of this project where we will:
- Introduce updates made to the Reference Architecture standards.
- Provide information on how to submit comments.
- Answer any questions you may have.
The focus of phase 2 is:
- Facilitating eCRF automation with the implementation of Biomedical Concepts into the model
- Enabling the model to handle more complex study designs including the representation of complex timing, branching and cycles.
- Adding protocol elements to help demonstrate population of structured data elements from the TransCelerate eCPT
Updated deliverables will include a logical data model, supporting Controlled Terminology, API specifications and a corresponding Implementation Guide. For more information, please visit the Digital Data Flow page.
Public Review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research.
Presenter(s)
John Owen, CDISC
Dave Iberson-Hurst, CDISC
TransCelerate Biopharma DDF Team
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
LB, MB & IS Domain Scope Changes for the SDTMIG v3.4 and Impact on Controlled Terminology
22 June 2023, 11am - 12:30pm EDT
The scope for the Immunogenicity Specimen Assessments (IS) domain is 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 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 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