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 reach out to us at cdiscwebinar@cdisc.org


Join CDISC and Embleema as we share our plans to develop new standards for experimental assays and bioinformatics protocols to facilitate monitoring the activity of Cell and Gene Therapy Products (CGTP). Initial projects will focus on the following three areas:

  • Protocols for experimental assays and bioinformatics pipelines for evidence generation and submission to the regulation bodies
  • Provenance and privacy with relation to the patient CGTP datasets
  • Longitudinal data linkage and patient engagement

The new standards are intended to create opportunities to accelerate drug development and regulatory approvals in personalized medicine and bring associated costs down.


Presenter(s)

Dave Evans, President and CEO, CDISC
Peter Van Reusel, CSO, CDISC
Rhonda Facile, VP, Partnerships and Development, CDISC
Robert Chu, CEO and Founder, Embleema
Vahan Simonyan, Ph.D. Chief Science Officer, Embleema

Language

English


CDISC, in collaboration with IMI’s Conect4Children (c4c) Project , is developing a Pediatrics User Guide, which builds on existing CDISC standards, and consists of cross-cutting pediatric data collection and data tabulation examples for use in pediatric clinical trials.

Join us for the Public Review webinar where we will:

  • Introduce the draft User Guide
  • Provide information on how to submit comments
  • Answer any questions you may have

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, Head PMO, CDISC
Richard Marshall, Lead Developer, CDISC

Language

English

QRS Office Hours

8 September 2022, 11am - 12:30pm EDT

REGISTER NOW!


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?

Presenter(s)

Dana Booth, Sr. Project Manager & QRS Co-Lead, CDISC
Diane Corey, Data Manager & Standards Expert, Critical Path Institute
Steve Kopko, Subject Matter Expert & Consultant, CDISC
Barara Lentz, Standards Engineer, Abbvie
Dr. Jordan Li, Terminology Expert, National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS)

Language

English

Genomics Findings Office Hours

15 September 2022, 11am - 12:30pm EDT

REGISTER NOW!


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


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


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