This repository contains an open-source tool for generating CDISC 360i study artifacts from a USDM study design. This software was developed as part of the CDISC 360i Program by the Define-XML Generation Project Team.
The Data Definition Engine (DDE) is a software tool created as part of the CDISC 360i Define-XML generation project. The DDE software populated the Data Definition Specification (DDS) model as JSON to facilitate the generation of study artifacts, such as Define-XML, ODM CRFs, Dataset-JSON shells, and the Trial Design datasets.
The DDE software will include multiple loaders and generators that use the DDS model. The loaders generate and load metadata content into the DDS model. The generators use the DDS model to generate the study artifacts.
Loaders will include the primary 360i loader that reads the USDM study design content, gets the Biomedical Concepts referenced in the SOA, retrieves the Dataset Specializations (DSSs), and uses the CDISC Library API to populate the DDS model. An alternative loader will be created to load the DDS model from an Excel spreadsheet template that matches the metadata spreadsheets used by many organizations today.
We welcome contributions to this project. All contributions to this repository fall under the below licenses. Please checkout Contribution for additional information. All contributions must adhere to the following Code of Conduct.
This project is using the MIT license (see LICENSE) for
code and models.
The content files, like documentation, are released under CC-BY-4.0. This does not include trademark permissions.
When you re-use the source, keep or copy the license information also in the source code files. When you re-use the source in proprietary software or distribute binaries (derived or underived), also copy the license text to a third-party-licenses file or similar.
When you want to re-use and refer to the content, please do so like the following:
Content based on Data Definition Engine (GitHub) used under the CC-BY-4.0 license.
This project is under active development, so there may be some rough edges, and you should expect changes. We are entering Phase 2 of the CDISC 360i Program, so there will be some exploratory work to come as we learn more about the new models used to generate an ADaM define.xml, for example.
This project is provided "as is" without any warranty or guarantee of suitability for any particular purpose.
We are in the process of consolidating our project work into this repository. Today, our models and code are spread across multiple repositories.
- DDS model (aka define.json)
- DDS USDM loader (create_define_json.py)
- Define-XML generator (define_generator.py)
- CRF generator (cdash_poc_odm132.py, cdash_poc_odm20.py)
Here are some related projects: