2024 Presentations
Opening Slides
CDSIC Road Map
Chris Decker & Anthony Chow
Overview of CDISC's strategic roadmap, goals, and the guiding principles to achieve them. CDISC's insights into the data standards pipeline and various initiatives, including COSA, OAK, and Biomedical Concepts, among others.
Analysis Results Metadata (ARM): Why and How to Do It
David Brega & Linda Collins
​Description of the history and current status of Analysis Results Metadata (ARM) standards at FDA, as well as detailing the rationale for its use. The presenters will also describe the technical requirements for creating ARM, and show the relationship between ARM content and statistical tables in a Clinical Study Report. They will show how the ARM fits into an Electronic Common Technical Document(eCTD) package and provide simple and complex examples of ARM documentation.
What is CORE and How Can It Help with Data Validation
Michelle Lumicao
An introduction to the CDISC Open Rules Engine (CORE), how to get access to it, and will provide some of the latest updates about CORE. For example, in January, CDISC announced a 3-year collaboration with the FDA to incorporate the FDA Business Rules into CORE.
“SAS Programmer (CDISC Req’d) – What It Means and How to be a Competitive Candidate”
Micky Salgado-Gomez
CDISC is frequently listed in job postings for programmers but what exactly does it mean? This presentation will describe what it can mean to be a programmer in a CDISC world since there is variability and not every company has the same needs. Whatever an analyst’s experience is today, there are realistic opportunities for personal growth to increase one’s contribution to their team and improve one’s marketability. This presentation will include keys to self-promotion in today’s landscape, general professional development, and pursuing your next opportunity.
“SAS Programmer (CDISC Req’d) – What It Means and How to be a Competitive Candidate”
Ali Henderson
CDISC is frequently listed in job postings for programmers but what exactly does it mean? This presentation will describe what it can mean to be a programmer in a CDISC world since there is variability and not every company has the same needs. Whatever an analyst’s experience is today, there are realistic opportunities for personal growth to increase one’s contribution to their team and improve one’s marketability. This presentation will include keys to self-promotion in today’s landscape, general professional development, and pursuing your next opportunity.
Customizing SDTM Data Can Be as Easy as Learning Your XYZs
Michael Marroquin
Determining which domains to use when creating SDTM data requires not only knowledge of CDISC Standards but also some creativity. Implementation Guides have left room for creativity when the required domain doesn’t exist. Although creativity is permitted, it is important to know when and how to stay within the lines to avoid confusion for the reviewer. This presentation will discuss some Dos and Don’ts using conventions beyond what has been published, in addition to the existing standards.