Public Review Dates |
Public Review Comment Period Start: Tuesday
Public Review Comment Period End: Thursday
Comments received after may not be addressed during the public review period but will be deferred to the next version of the USDM.
Please direct any questions to John Owen (jowen@cdisc.org)
Instructions for Public Review |
- The public review version of the UML diagram is available on the USDM GitHub site
- usdm-uml.png - picture format
- usdm-uml.xmi - XMI format (See here for more information on .XMI format
- usdm-uml.qea - New Enterprise Architect format
- An informative version of the USDM UML is available here
- A list of UML model changes between USDM v2.0 and USDM v3.0 is available here
- Smaller sub views of the model can be found here
- If you are unfamiliar with UML, Section 5.6 of the BRIDG Users Guide might be used as a model for a “Basics of UML” guide for DDF
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Unified Study Definition Model (USDM) Class DiagramThe USDM Class Diagram is a UML class diagram that functions as the Study Definitions logical data model (LDM). The class diagram as LDM depicts the classes and attributes that represent data entities and the relationships between those entities needed to support a conformant Study Definitions application. The class diagram includes a data dictionary that defines each of the classes and attributes to provide the semantics needed to implement the model consistently. The purpose of the LDM is to provide a normative standard to the solution implementer in order for them to create and implement a physical model. The LDM does not attempt to be inclusive of every class, attribute, and relationship implemented by any given solution. Instead, the LDM describes all elements for a conformant solution based on Release 1 and 2. It provides input into the solution architecture with the expectation that every effort will be made to ensure the solution architecture aligns with the RA LDM. The LDM represented by the class diagram may be implemented in a variety of physical data stores, including relational databases, property graph databases, RDF triple stores, document databases, and others. The semantics represented in the LDM and its data dictionary support a uniform understanding of the Study Definition data elements to improve interoperability. The LDM will be used to define the resources available in the API specification, and these resource definitions represent the data exchange format for applications implementing the API. The class diagram references both CDISC and non-CDISC industry standards and terminology systems where relevant. It will be developed for compatibility with all other existing CDISC Standards that model protocol concepts, to ensure consistent terminology and relationships are used in USDM. Where the class diagram references external standards, CDISC will document these connections in order to help explain to the user community the provenance of the links. For example, the Study Definition class diagram includes references to new CDISC Biomedical Concepts, CDISC foundational standards, as well as CDISC controlled terminology. The data dictionary built into the class diagram will include references to the CDISC Library for retrieval of all CDISC content. Content from other standards and terminology systems will be incorporated where appropriate into the LDM, such as HL7, LOINC, Common Protocol Template, ICH M11, and others, either directly or through external linking, with the intention of extending interoperability in the future to data exchange standards such as HL7 FHIR. The class diagram also depicts essential elements of a study protocol including but not limited to study objectives, endpoints, and the schedule of activities (SoA). |
- The public review version of the Controlled Terminology (CT) is available on the USDM GitHub site
- usdm_ct.xlsx - Microsoft Excel format
- A list of CT changes between USDM v2.0 and USDM v3.0 is available here
- The link to the left takes you to the USDM GitHub - Click on the view raw link or the download icon (top right) to download the Excel file
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CDISC Controlled Terminology to Support USDMThe use of standardized terminology is an essential element of interoperability. CDISC currently leads the Protocol Terminology project which develops the semantics for commonly used research protocol entities. CDISC works in collaboration with the NCI Enterprise Vocabulary Services and CDISC volunteer subject matter experts to develop this controlled terminology package. The Protocol Terminology project supports the CDISC foundational standards for the Protocol Representation Model (PRM) and Clinical Trial Registry XML (CTR-XML). New control terminology needed to support the Reference Architecture will be developed with reuse of terminology already developed for the protocol terminology package and other CDISC controlled terminology packages as appropriate. This updated Reference Architecture controlled terminology package will be published as a standalone package alongside other CDISC Controlled Terminology. |
- The public review version of the API Specification is available on the USDM GitHub site
- usdm_api.json - JSON format (learn more about JSON)
- usdm_api.json - YAML format (Learn more about YAML)
- Compare the updated API specification on the left to the USDM v2.0 API using a simple JSON Comparison tool
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Application Programming Interface (API) SpecificationA standardized API provides a standard interface for a common set of core services that must be supported by all conformant solutions. A standard API will enable application developers to build solutions that can use the core services of any conformant Study Definition. Data standards, controlled terminology, data exchange standards, and APIs work together to create an optimal environment for interoperability between conformant systems. A Study Definition REST API will be specified using the OpenAPI Specification (OAS) version 3.0. As a machine-readable format, OAS can be used to generate not only interactive documentation, but also source code to aid developers creating software implementing the specification. The CDISC Library and ODM v2.0 also publish API specifications using these formats. The CDISC Library, ODM v2.0, HL7 FHIR, and the DDF Study Definition API form a growing set of standard APIs to improve interoperability and automation in clinical trials. Much like the CDISC Library API, the Study Definition API will support a range of media types including JSON and XML. In addition to providing an interface for applications to retrieve study design information, the Study Definition API enables clients to create, update, and remove Study Definition content assuming the user’s role permissions support the activity. Thus, the API provides access to Study Definition services such that alternative user interfaces and applications can be developed to extend or exchange information with any given Study Definition tool. |
- The public review version of the USDM Implementation Guide (USDM-IG) is available on the CDISC WIKI
- A PDF version of the USDMIG is available in the USDM GitHub site ( use the download icon (top right) to download the pdf file)
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USDM Implementation GuideA CDISC Implementation Guide will guide the organization, structure, and format of CDISC standards and provide users with the information required to successfully implement a CDISC standard. The USDM Implementation guide will therefore inform users about implementation of the Unified Study Definition Model (USDM) Class Diagram, CDISC Controlled Terminology to Support USDM, and Application Programming Interface (API) Specification. The USDM Implementation Guide should be used alongside the other deliverables in order to fully understand and enable users to implement the USDM model. |
The above information is also available as a single downloadable USDM.zip file
Public Review Webinar
- We invite you to register and attend the DDF Public Review Webinar on Thursday 11:00am-12:30pm US Eastern Time, where representatives from the TransCelerate Biopharma and CDISC DDF teams will present on the updates made to the USDM during this phase of development, as well as providing information on how to provide public review comments.
- A recoding of the webinar will be posted here
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- Familiarise yourself with the Digital Data Flow Project:
- Listen to the Public Review Webinar linked below
- Familiarise yourself with the DDF project and USDM using the found in the Other USDM Resources section of this page
- Review the USDM materials (UML diagram, Controlled Terminology, API, USDMIG) provided in the Location of Materials for Public Review section below
- Either review the materials on-line in the USDM GitHub and USDMIG WIKI sites
- Or download the zip file.
- Enter any review comments into JIRA using the instructions in the following sections below:
Instructions to create a JIRA comment for the USDM Implementation Guide section
Instructions to create a JIRA comment for the UML, CT and API Deliverables section
Location of Materials for Public Review |
There are two ways to view he USDM materials for Public Review.
The first is to use the table below to navigate to the CDISC USDM GitHub and CDISC USDMIG Wiki site
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USDM UML Logical Model |
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USDM Implementation Guide |
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The second way is to download the single USDM.zip file
Public Review Webinar |
The list below contains useful information if you are new to Digital Data Flow and the Unified Study Definitions Model (USDM) including:
- How to find introductory information on DDF
- Overview of the USDM
- Biomedical Concepts in the USDM
- Current developed test data
- Using your own study using the test data tools
- We invite you to register and attend the DDF Public Review Webinar on Thursday 11:00am-12:30pm US Eastern Time, where representatives from the TransCelerate Biopharma and CDISC DDF teams will present on the updates made to the USDM during this phase of development, as well as providing information on how to provide public review comments.
- A recoding of the webinar will be posted here
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Other USDM Resources |
The list below contains useful information if you are new to Digital Data Flow and the Unified Study Definitions Model (USDM) including:
- How to find introductory information on DDF
- Overview of the USDM
- Biomedical Concepts in the USDM
- Current developed test data
- Using your own study using the test data tools
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This page contains useful resources to help you get started with the Digital Data Flow (DDF) and the Unified Study Definitions Model (USDM).
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This page contains useful resources to help you get started with the Digital Data Flow (DDF) and the Unified Study Definitions Model (USDM).
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Instructions for Public Review
- Download the Review Materials zip file from the link above.
- The CT, API and UML deliverables can be found in the following directory of the zip file >> USDM v2.0 - Draft for Internal Review.zip\DDF-RA-1.11.0\Deliverables
- Navigate to each directory to see the deliverables
- API has both .yaml and .json formats
- The CT is in Excel format - There is a CT file and also a change log that lists all of the CT changes since version 1.0 was released last August.
- The UML is in .eapx (Enterprise Architect), .png (picture file) and .xmi (XML format) as well as a change log from version 1.0 released last August
- Note that the Implementation Guide folder contains a PDF of the WIKI version of the USDM-IG as well as a folder of JSON examples of study designs in USDM format.
- Use the link above to navigate to the USDM Implementation Guide version on the WIKI.
- Please read Information on Instructions for Reviewers and also How to Read this Document for additional information on performing the review of the ISDM Implementation Guide
- Perform your review
- Enter any review comments into JIRA - See instructions below
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Instructions to create a JIRA comment for the USDM Implementation Guide |
Note that the USDM Implementation Guide has been developed in the CDISC WIKI and therefore JIRA comments can be made direct in the WIKI
Please see the USDM Implementation Guide (USDM-IG) v3.0 landing page and the Instructions for Reviewers section of the USDM IG
Instructions to create a JIRA comment for the UML, CT and API Deliverables |
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Public Review Issue Summary |
Provides an overview of Public Review Comments that have been received (note you must have a CDISC WIKI/JIRA account to access the Public Review Issues)
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See below for a detailed list of Public Review Comments |
Provides more detail on Internal Public Review Comments that have been received. If the same comment has already been made you may want to add a comment to the JIRA ticket to add your comments, or if you feel it is best to create a new JIRA ticket please do so (note you must have a CDISC WIKI/JIRA account to access the Public Review Issues).
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