Next Webinar - 1st May 2024 14:00 BST
Title: USDM overview and use cases. Register here: Join the guestlist – CDISC Unified Study Definition Model (USDM) webinar – Free Conference Call, Wed 1 May 2024 2:00 PM - 2:45 PM (tickettailor.com)
Description:
The TransCelerate Digital Data Flow initiative aims to digitize the study design to enable automated downstream processing. To achieve that, they have started a collaboration with CDISC to create a Unified Study Definition Model (USDM). This data model with the corresponding API and controlled terminology enables development of systems for storage and exchange of study designs. Version 3.0 of the USDM will be released in April 2024. With this new version, the protocol can be covered completely as well in digitized as in readable format. The presentation includes an overview of the data model and it’s use cases including the mapping to SDTM study design domains.
Presenter:
Berber Snoeijer has more than 25 years experience in the industry. She is the owner of Clinline, a consultancy company dedicated to optimize clinical research data processes. She is, as a contractor working for CDISC and as technical team lead involved in the development of the USDM data model.
Huge thanks to Will for joining us on the CDISC UK Network Webinar on 23rd November!
Dr William Stevens Ph.D, Nuffield Department of Population Health, Oxford University presented on "Use of CDISC Standards in the RECOVERY Trial of COVID-19 Treatments".
The RECOVERY COVID-19 platform trial has identified several effective treatments, and several ineffective treatments. Data is collected on an eCRF and also extracted from electronic healthcare systems.
Treatments are added and removed over time, protocols and CRFs are under continual revision, and analyses and regulatory submissions are needed for some treatments while others continue.
Sometimes disagreements are expected in electronic healthcare data, this means that SDTM cannot faithfully represent what happened to the participant. This presentation will describe the approach taken to create high quality SDTM and use best estimates in deriving ADaM.
Watch the recording here: https://fccdl.in/cRLP5Gx5Tu
