Session 29 - CDASH has three ongoing projects? No way! Tell me more

  • #communicate
Wednesday, September 16, 2020: 10:15 AM - 11:15 AM
/ CEU Credits:0.2


Session Chair
Dan Crawford
Senior Director, CDMS Strategy
Veeva Systems
Dawn Kaminski
Senior Director, Data Strategies
eClinical Solutions
Jorge Torres Borrero
Clinical Data Manager
Lung Biotechnology PBC
Peter Van Reusel
Chief Standards Officer


The CDISC organization has three ongoing projects that when final, will impact Data Management in a significant way. Do you know what they are and how they could impact your day to day operations? Come join our session and learn what they are and hear the latest updates.

  • CDASH CRF Library Project - For the first time the team will designing CRFs (based on a specific SDTM version) that will be machine readable and made available to the public.¬†
  • CDASH SAE 2.0 - The team is updating and developing data standards for SAE reporting while ensuring alignment with CDASH and SDTM for electronic submissions. It's anticipated that up to 15 new variables across CDASH/SDTM will need to be created.¬†
  • CDISC 360 - This is one of the most ambitious projects to be undertaken by CDISC. End to end automation of standards from data collection (CDASH) to SDTM to ADaM to analysis output (tables, listings and figures).

Take advantage of this unique opportunity and explore how data standards are evolving from team members working on these projects.



1. Understand the fundamentals of the CDASH Library Project and how that may impact the day to day operations of a Data Manager
2. Understand the key elements of the SAE CDASH 2.0 Project so the Data Manager stays current on industry practices
3. Understand CDISC 360 and how standards can shape the way we do our work as Data Managers in the future
4. Understand the exciting projects that are going on in our industry with the hopes it inspires people to volunteer


CDM Certification Competencies::
Clinical Trials Processes, Roles, and Responsibilities,CRF Design,SAE Reconciliation and Safety Review

Target Audience:
Programmer,Data Managers,Safety Coordinator