Study Definitions Repository (SDR) Reference Implementation (RI)
The SDR RI is a working instance of a Study Definitions Repository that has been developed based on the CDISC Unified Study Definitions Model Reference Architecture.
Disclaimer
The materials shared here are intended to be used solely for understanding DDF and the SDR Reference Implementation.
These materials are not intended to guide the study definition process or configuration of clinical systems. Results of those activities are solely the responsibility of the user of the scripts and not the developers.
For more information on the DDF initiative on the TransCelerate BioPharma Inc. website, click here.
Getting Started with the SDR RI Codebase
The Study Definitions Repository (SDR) Reference Implementation is a working instance of a Study Definitions Repository that has been developed based on the CDISC Reference Architecture (RA) which is part of the Unified Study Definitions Model (USDM).
For details and documents regarding the RA and USDM, please go to the CDISC Digital Data Flow website.
TransCelerate’s intent is to facilitate the development of open-source, vendor-agnostic solutions to facilitate digital data flow (“DDF”). Accordingly, while the SDR is currently developed with Microsoft Azure, the intent is for users to be able to implement the elements of DDF in any environment or system.
SDR RI Codebase as Open Source & GitHub
The SDR Reference Implementation has been designed and deployed to be open-source and vendor agnostic. The goal of having an open-source, vendor agnostic solution is to create a platform for both innovation and collaborative interoperability across the industry.
GitHub is the platform where the SDR RI code is published.
New to GitHub? Click Getting Started with GitHub for some guidance on accessing and using GitHub.
DDF Community and Participation
The DDF Community is about working together under an open-source framework toward continuous improvement, learning from each other, and sharing information.
Please refer to the DDF Community Overview for information and expectations about:
- Community Values
- Contributor Covenant Code of Conduct
- Contribution License Agreement
NOTE - It is highly recommended that all users that will be engaging with DDF read through all the DDF Community content.
SDR RI Releases
Please refer to the “Releases” information under the Platform, API, and UI repos as indicated in the next section.
DDF GitHub Repositories
The SDR Reference Implementation codebase is separated into different repositories for ease of use.
| Repository | Description |
|---|---|
| ddf-home | This repository holds all public facing website content for the DDF Initiative. It contains the overview of the DDF initiative, as well as the associated open-source information such as Contributor License Agreement (CLA), Community Code of Conduct, contact information, and all documentation on accessing the SDR Reference Implementation. |
| ddf-sdr-platform | This repository holds the scripts written in Terraform for provisioning the underlying cloud hosted infrastructure to run the SDR platform, initially focused on the Microsoft Azure platform. |
| ddf-sdr-api | This repository holds the ASP.NET Core API layer that comprises the core of the SDR platform |
| ddf-sdr-ui | Several user interface features including search, view, and compare functionality was created to support the SDR. This repository holds the ASP.NET Core user interface layer code developed for these features |
| ddf-sdr-support | Core documentation to help new users get started with the DDF SDR system. |
Each repository contains supporting documentation for access and installing the code.
How-To Video(s)
NOTE: The video refers to SDR 3.0, but that all the functionality is the same in SDR 4.0, minus the authentication.
| Video | Description |
|---|---|
| DDF Study Definition Repository Overview | This video provides an overview of the Study Definition Repository (SDR), a component output of the TransCelerate Digital Data Flow (DDF) Initiative, and a walkthrough of the main features covering the User Interface, the API and deployment configurations is presented. |