Upcoming Webinars

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

The ODM v2.0 Public Review Webinar highlights the most significant changes to version 2.0 of the Operational Data Model standard.
 

ODM v2.0 builds on ODM’s proven strengths while modernizing and improving the standard. Objectives for ODM v2.0 include addition of the study design model, inclusion of Define-XML metadata, improved semantics, more dynamic data structures, better traceability, improved support for RWD such as HL7 FHIR, explicit support for data queries, expanding media types to include JSON, enhancements to support advanced CRFs, support for tabular dataset exchange, basic text formatting, support for null flavors, improved data representation, and numerous others.

Presenter(s)

Sam Hume, VP, Data Science, CDISC

Language

English

The CDISC Open-Source Alliance (COSA) invites you to participate in the {admiral} Virtual Hackathon. The Hackathon is a unique opportunity to get familiar with the first generation of open-source tools for clinical reporting, in particular {admiral} — an R package for ADaM dataset creation.

 

What is {admiral}?

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.

 

Hackathon Objective

Participants will get access to a set of SDTM datasets with accompanying specifications and be tasked with transforming these SDTM datasets to analysis datasets using {admiral} and a set of additional R packages from the pharmaverse.

This is an excellent opportunity to upskill in R and become part of a vibrant community who develops open-source R packages for clinical reporting purposes. This community will also serve as a great resource to answer any R or {admiral} questions you may have along the way.

Pre-Hackathon Workshop

We will be hosting an "Introduction to R for SAS Programmers" workshop on 17 January for R aficionados and long-time SAS programmers. Topics covered in the workshop will serve as a strong foundation upon which to build in the Hackathon.

Additional Details

• Participants will receive access to an RStudio Cloud workspace; there will be no need to install R and RStudio on machines.
• Participants will be asked to upload their final R programs using a webform. The submitted code will be run by the organizers and compared to the expected ADaM in a proc compare like fashion. Participants who get a match between "their" dataset and the expected ADaM will have the opportunity to win a prize.
• The spirit of this event is collaborative not competitive; it's about learning and upskilling as well as becoming part of a vibrant community. There will be no public leaderboard or anything like that.

Key Dates

• 17 January 2023: Introduction to R for SAS Programmers Workshop
• 26 January 2023: Admiral Hackathon Kickoff
• 1-28 February 2023: Admiral Hackathon

Presenter(s)

Language

English

The CDISC Open-Source Alliance (COSA) invites you to participate in the {admiral} Virtual Hackathon. The Hackathon is a unique opportunity to get familiar with the first generation of open-source tools for clinical reporting, in particular {admiral} — an R package for ADaM dataset creation.

 

What is {admiral}?

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.

 

Hackathon Objective

Participants will get access to a set of SDTM datasets with accompanying specifications and be tasked with transforming these SDTM datasets to analysis datasets using {admiral} and a set of additional R packages from the pharmaverse.

This is an excellent opportunity to upskill in R and become part of a vibrant community who develops open-source R packages for clinical reporting purposes. This community will also serve as a great resource to answer any R or {admiral} questions you may have along the way.

Pre-Hackathon Workshop

We will be hosting an "Introduction to R for SAS Programmers" workshop on 17 January for R aficionados and long-time SAS programmers. Topics covered in the workshop will serve as a strong foundation upon which to build in the Hackathon.

Additional Details

• Participants will receive access to an RStudio Cloud workspace; there will be no need to install R and RStudio on machines.
• Participants will be asked to upload their final R programs using a webform. The submitted code will be run by the organizers and compared to the expected ADaM in a proc compare like fashion. Participants who get a match between "their" dataset and the expected ADaM will have the opportunity to win a prize.
• The spirit of this event is collaborative not competitive; it's about learning and upskilling as well as becoming part of a vibrant community. There will be no public leaderboard or anything like that.

Key Dates

• 17 January 2023: Introduction to R for SAS Programmers Workshop
• 26 January 2023: Admiral Hackathon Kickoff
• 1-28 February 2023: Admiral Hackathon

Presenter(s)

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?

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.

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

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)

Language

English