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Digital Data Flow

Getting Started on DDF

TransCelerate has developed guidance to support people who are new to DDF and as well as those who want to dive right in. Depending on a person’s role in an organization and level of understanding of DDF, they can reference different starting points.

For guidance on managing changes associated with adopting to DDF within an organiation, click Transformation Tools.

Starting Point: General Awareness

Follow these links for information about DDF, benefits, and initiative outputs:

TransCelerate has created informational videos to support the understanding of some key concepts in the USDM v2.0 and/or SDR v2.0.

Video Description
Supporting Automation of Case Report Forms Using Biomedical Concepts Short video introducing Biomedical Concepts and the benefits of this data model concept in the study lifecycle
Time Points: Supporting Protocol Digitization with Complex Timing Components Short video introducing Time Points and how it can be used to support complex studies designs
Integrating Clinical Content & Reuse (CC&R) and Digital Data Flow (DDF) Initiatives Short video introducing the synergies between TransCelerate’s CC&R and DDF initiatives.

Starting Point: Active Exploration

Click for information about USDM, SDR Reference Implementation, and Open Source/GitHub:

USDM SDR Reference Implementation Open Source & GitHub
- DDF USDM Overview Video
- Latest USDM Version from CDISC
- DDF SDR Reference Implementation Overview Video - DDF Community
- GitHub Support

See some examples of what is possible with DDF:

[Nov 2023] DDF Technical Architecture Scenarios Tool

Link to Resource

What is it and why?

Each organization considering the adoption of USDM and DDF concepts has its own unique ecosystem of technology solutions as well as custom processes in working with data across the solutions. To provide guidance and support, this document has been developed to highlight several potential scenarios for technical implementation. The scenarios range from having all technical components supporting study design to electronic data capture fully-compliant to the Unified Study Definitions Model (USDM), to having partial application of the USDM in certain portions of the data flow process. While this tool is not a rundown of all possible implementations, the DDF team hopes that these examples help kickstart the thinking about what may be possible.

Who may benefit the most from this tool?

- Technical Architects

Starting Point: Proactive Adoption

Stakeholders with a good understanding of DDF who want to start actively engaging with the technology framework and platform can access the SDR Reference Implementation using the following link.

Link Description
SDR RI Codebase
(click to assess)
A way to access the codebase to install the SDR Reference Implementation locally on a company’s technology environment.