DDF User Training
From Clinical Strategy to Filing: Automating the Clinical Data Flow Journey
This training aims to show clinical study team members their involvement with a clinical data point through the stages from strategy through marketing authorization submission.
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 the USDM is one approach, Digital Data Flow can also be achieved using other models.
Course Description
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In this training course, you’ll see how a clinical data point moves from strategy through to marketing authorization submission —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.Learning Objectives
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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.Who Should Take This Course
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This course is designed for anyone involved in the clinical data lifecycle, especially those who contribute to or rely on the Digital Data Flow. Whether you're a clinician building a study portfolio, writing content for a marketing authorization submission, supporting data standards, or part of the data transformation and delivery process, this training will help you see how your work connects to the bigger picture. It’s ideal for roles across: - Clinical content development - Data standards and governance - Study setup and design - Data transformation and delivery - Regulatory and marketing authorization submission teams Even if you're not hands-on with data every day, understanding how it flows digitally can help you collaborate better cross-functionally and add more value to the process.Recommended Experience Level for Taking the Course
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Before taking this course, learners should have: - A basic understanding of clinical trial processes (e.g., study design, data collection, and marketing authorization submission workflows) - Familiarity with roles such as clinical strategic lead, clinical scientist, medical scientist, medical monitor, medical writer, study designer/builder, data manager, clinical data programmer, statistician, statistical programmer or regulatory strategist, or safety lead. - A general awareness of clinical data standards (e.g., CDISC, SDTM) is helpful but not required. - No technical background needed—this course focuses on concepts and connections, not programming.Here are some reference videos to learn about DDF. - General Information: Digital Data Flow Initiative - USDM Information: DDF: Unified Study DEfinitions Model (USDM) Overview - SDR Information: DDF: Study Definitions Repository (SDR) Reference Implementation Overview - Biomedical Concepts Information: DDF: Supporting Automation of Case Report Forms Using Biomedical Concepts - Timepoints Information: DDF: TimePoints - Support Protocol Digitization with Complex Timing Components - Benefits Information: DDF: Benefits of Digital Data Flow (DDF)
DDF Use Case: From Clinical Strategy to Filing: Automating the Clinical Data Flow Journey
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