Upcoming Webinars

Join us for an update from the TMF Reference Model Steering Committee.

Agenda:

• Membership Update
• TMF Management Plan Template Update
• Report out of the 2022 TMF RM Survey
• Upcoming Events

Presenter(s)

Language

English

CDISC recently released the CORE Minimum Viable Product (MVP), which allows users to run conformance checks on sample CDISC datasets to explore CORE's features and functionality.

CDISC is looking for volunteers with knowledge of SEND, SDTM, or ADaM to help add CDISC Conformance Rules into CORE. We invite you to participate in this important initiative that will help test study data for conformance to CDISC standards as well as to regulatory and sponsor-specific conformance rule sets.

Expected engagement:

• Time Period: 3 - 6 months, or longer, if able
• Hours per Week: 2 - 4 hours in addition to meeting attendance
• Weekly Meetings and Workshops: Recorded and available for review

Join us for an onboarding webinar where we will explain tools and processes that will prepare you serve with our very active, global team. The webinar will be followed by a Q&A session; you can submit questions for the Q&A session in advance of the webinar when you register.

This webinar is open to anyone interested in serving on the CORE team and will prepare attendees to participate in the hands-on CORE Workshop at or PHUSE EU Connect. We highly recommend you attend this webinar if you plan to attend the Workshop. The Workshop is an opportunity to learn from CDISC experts and other seasoned rules developers about the CORE Project, using the CORE Rule Editor, and building your skills to enable you to develop your own rules and customize them for your data requirements

Note: Webinar and workshop participation is not required to become a CORE volunteer.

CDISC needs you! CORE is a community-driven solution. Continued volunteer participation and community support remain critical to its success.

Presenter(s)

Anthony Chow, Head of Data Science Development, CDISC
Amy Palmer, Head of Standards Development, CDISC
Dana Booth, Project Manager, Foundational Standards and QRS Co-lead, CDISC
Gerry Campion, Software Engineer, CDISC
Nick De Donder, Head of Data Standards, Business & Decision Life Sciences, CORE Product Owner

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.

• Smart Submission Dataset Viewer – Allowing to inspect SDTM, SEND and ADaM submission files in the modern CDISC Dataset-XML standard format.
• CORE – CDISC’s open-source execution engine that delivers a governed set of unambiguous and executable Conformance Rules.
• Rule Editor – A web-based tool for authoring machine-readable Conformance Rules, which allows users to create rules according to a set schema.

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

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.

Presenter(s)

Glenn Barnes, Senior Consultant for Clinical Specimen and Data Management, CDISC
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