Training DescriptionThis training aims to show clinical study team members their involvement with a clinical data point through the stages from strategy through marketing authorization submission in an environment that has deployed DDF elements such as CDISC’s USDM standard and DDF tools and processed developed by TransCelerate.The course introduces the CDISC USDM (Unified Study Definitions Model), a standardized reference architecture that supports the digitization and automation of clinical trial protocols. While theUSDM is one approach, Digital Data Flow can also be achieved using other models.In this training course, you’ll see how a clinical data point moves from strategy through to marketing authorization submission in an environment that has deployed DDF elements —and how every contributor plays a key role in that end-to-end journey.The video and downloadable schematic shows the full vision of DDF, highlighting the interdependencies on other roles as we move from clinician portfolio building to submission writing, and how each step is related. AttributionThis course was developed and is maintained by TransCelerate BioPharma as part of the Digital Data Flow initiative. It is reproduced in the CDISC internal curriculum with TransCelerate's permission. Learning Outcomes By the end of this course, learners will be able to: - Describe the key stages of the DDF process, from study strategy to marketing authorization submission. - Identify the roles involved and interdependencies from portfolio building and writing for submission within the DDF framework. - Trace the flow of a clinical data point) through the end-to-end process. - Identify where to access additional training and resources for deeper learning. References TransCelerate DDF Training Page TransCelerate DDF Overview Page CDISC DDF Page Price: $0.00 Related Courses Understanding USDM: On-Demand Training Online (self-paced) On-Demand, Self-Paced Online View Course Return to Catalog