Why is it needed?
As the CDISC implementation community increased, the need for new implementers to better understand the CDISC landscape became apparent.
What needed to happen?
Volunteers from the PHUSE Community agreed to establish a PHUSE project, in collaboration with CDISC, at the PHUSE Computational Science Symposium in Silver Spring, Maryland in 2018. The team were tasked with identifying the needs (regulatory requirements, implementation options and best practices) of new CDISC implementers and providing a central starting point where newcomers could be guided towards all aspects of CDISC data standards implementation. The project was established under the Optimizing the Use of Data Standards Working Group, with the goal of developing a "CDISC Primer" that is freely available to the public.
What has been achieved?
The Primer was developed through intense, productive global teamwork from both organisations. Progress was presented at various events, as the deliverables were made ready for publication. We are pleased to announce the final publications of these deliverables are housed on our respective websites.
1. How to Get Started with CDISC
3-Minute Videos Covering:
- Foundational Standards
- Controlled Terminology
- Therapeutic Area User Guides
- Regulatory Requirements
2. Links Among CDISC Standards
3. Traceability
To hear more about this collaborative achievement, be sure to register for our Webinar Wednesday event scheduled on 25th November. Registration details to follow.
The CDISC Primer Project Leaders – Beate Hientzsch, Bess LeRoy, Yvonne Moores and Wendy Dobson – would like to thank everyone who has contributed to the project over the last few years. If you have any questions for the team, please email them to workinggroups@phuse.eu.
