CDISC, in continued collaboration withTransCelerate’s Digital Data Flow Project, has updated the USDM reference architecture, which will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards. CDISC invites you to submit comments on the draft v3.0 of the Unified Study Definitions Model (USDM) during the 30-day Public Review period.
The focus of Phase 3 is:
Representation of draft ICH M11 CeSHarP (Clinical electronic Structured Harmonised Protocol) elements in USDM
Addition of elements to the USDM to demonstrate automated population of selected SDTM Trial Design datasets
Addition of elements to the USDM to demonstrate automated population of selected Clinical Trial Registry fields
Updates to the USDM to cater for more Complex Studies/Cohort Studies
USDM Model Enhancements
Deliverables include a logical data model, supporting Controlled Terminology, API specifications, and an associated Implementation Guide.
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.
The above information is also available as a single downloadable USDM.zip file
Public Review Webinar
We invite you to register and attend theDDF 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
Page properties
hidden
true
The Public Review Webinar is available here(scroll to the end of page to access the recording).
assets available to help you understand the vision of he Digital Data Flow initiative including the key deliverables from the project:
CDISC Unified Study Definitions Model (USDM) and API specifications–the foundational standards to create a common, digital data model and method for exchanging protocol information
Study Definitions Repository (SDR) Reference Implementation and associated source code available in open source–a functioning, example approach to connect systems that produce protocol information with those that consume it to drive study operations – in the form of a reference implementation that stores and facilitates the exchange of protocol information
Engagements with implementers (sponsors, vendors, CROs) who play a critical role in leveraging standards in their software and their protocol digitization approach
There is an introductory video to the initiative as well as other useful general information, webinars, videos and sponsor company transformation tools.
I want to find out more information on the current USDM development activities
Listen to the DDF USDM Phase 3 Introductory Webinar which provides an overview of activities in Phases 1 and 2 as well as the development plan for Phase 3
How do I become an SME on the CDISC DDF USDM Development Team
Visit the CDISC DDF Web Page and navigate to the participate tab for instructions on how to sign-up.
I want to find the latest official release information of the USDM
Page and navigate to the release information tab for information on the latest official release (V2.0 release June 2023). The files tab will allow you to download the latest released version of the USDM from Phase 2.
I want to see current draft version of USDM from version 3
During Phase 3, the CDISC development team have been releasing draft versions of the USDM for review and comment prior to the public review (Anticipated Q1-2024). All the releases can be found under the Development Dashboard tab on this WIKI site.
Feel free to review the current release and also provide your comments prior to public review. There are instructions at the top of the dashboard page on how to submit comments in the CDISC Jira Comment Management system.
You can also visit the CDISC USDM GitHub where you will find the most up to date versions of the UML, CT, API in the deliverables folder - Note that the USDM Implementation Guide (USDMIG) is developed on the CDISC WIKI, so visit the USDMIG site to see the latest version of the IG, although at key times during the project (for example public Review) the USDMIG is exported to PDF and stored in the IG folder of the GitHub Deliverables.
On the GitHub you will also find the Documents folder which contains useful information to help you understand the USDM. The USDM Model Information Graphic provides a visualization of the UML is a user friendly format and is kept up to date with each draft release (note that this is informational only - the normative content is always to the USDM UML diagram). The DDF USDM Model Walkthrough provides a slide by slide walkthrough and explanation of the model - you can also access a more interactive version on the DDF Miro Board (P: CDISC-DDF-SME) - Just follow the arrows to walkthrough the model. Finally the examples folder shows several examples of study protocols, a corresponding Excel representation of the study design and a JSON output in USDM format. See below for more information about the example test data and how you can create your own to help in your understanding of the USDM.
I want help to explain the USDM Model
On the GitHub you will find the Documents folder which contains useful information to help you understand the USDM. The USDM Model Information Graphic provides a visualization of the UML is a user friendly format and is kept up to date with each draft release (note that this is informational only - the normative content is always to the USDM UML diagram). The DDF USDM Model Walkthrough provides a slide by slide walkthrough and explanation of the model - you can also access a more interactive version on the DDF Miro Board (P: CDISC-DDF-SME) - Just follow the arrows to walkthrough the model. Finally the examples folder shows several examples of study protocols, a corresponding Excel representation of the study design and a JSON output in USDM format. See below for more information about the example test data and how you can create your own to help in your understanding of the USDM.
Page and navigate to the release information tab for information on the latest official release (V2.0 release June 2023). The files tab will allow you to download the latest released version of the USDM from Phase 2.
I want to find out more information on how Biomedical Concepts fit into the USDM
Watch the USDM and Biomedical Concepts webinar that was conducted on to provide users with information on how Biomedical Concepts fit into the USDM.
I want to see some examples of how study designs are represented in the USDM
You can visit the CDISC USDM GitHub and in the examples folder there are several examples of study protocols, a corresponding Excel representation of the study design and a JSON output in USDM format. See below for more information about the example test data and how you can create your own to help in your understanding of the USDM.
I want to use my own study to show how this is represented in the USDM
CDISC has created several examples study designs for reference. There are tools available that can help you create an example of how your own study can be represented in USDM. Follow the steps below to help you get started with using the available tools.
Warning
Please note that the tools below are not a validated study builder tools and are developed only as an aid to help user start to understand the USDM model and the corresponding JSON representations.
The tools do not 100% replicate the full breadth of the study design
Development work in ongoing and the tools and Excel utilities will evolve
If using your own study design do no expect a 1:2:1 100% match - the USDM is transforming the way we develop study designs and protocols
Listen to the Webinar that CDISC conducted for attendees of the EU PHUSE Connect 2023 Workshop in Mastering the USDM (also the slides form this webinar)
Review the Slides from the workshop to help understanding of more complex areas of the model such as Inclusion/Exclusion criteria, timelines, biomedical concepts, and footnotes
It is also helpful to have an understanding of the USDM model, the USDM Model Information Graphic provides a visualization of the UML and in combination with the DDF Miro Board (P: CDISC-DDF-SME) - you can follow the arrows to walkthrough the model to aid your understanding.
CDISC has developed an Excel tool that can be used to plug in your own study design information and convert to JSON - Please note that this tool is not a validated study builder and is developed only as an aid to help user start to understand the USDM model and the corresponding JSON representations. You can download a partially complete Excel file as a starter - this will help you understand where some of the study design components fit into the Excel sheet by seeing an already completed example (this is based on the Example LZZT CDISC Pilot Study) . Note that this version of the Excel file was based on a draft version of the USDM, as development is still ongoing the Excel tool will be updated to represent additional features added during he draft releases. A starter version of the spreadsheet is also available here (also refer to the "usefulInfo" sheet).
Web Tools(no need to install - these will run from a web browser)
Once the Excel file is downloaded there are several resources to help understand the structure of the Excel tool and how to go about starting to complete the Excel tool for yourself
The utility readme file will provide some additional information about the set-up of each of the excel worksheets - head to the Format of the Workbook Section.
The following infographic will also help is showing the relationship between the various worksheets - this allows you to start understanding how the worksheets link and what information you need to provide in the linked worksheets for the tool to work.
You can then start to complete the Excel workbook for your study design working though worksheet by worksheet and using the information to a. and b. above to help understand what is required.
Once you have completed the Excel tool (or in fact partially completed) you can then use the Python web tool to up load and check your Excel file - Note that instructions to do this are in the Webinar (forward to 22mins 6 Seconds)
Image ModifiedReview/fix your any errors that have been reported and rerun the upload.
Image Modified Download and review the JSON output to see how the study design is represented in JSON
Image ModifiedReview the timeline graphic that is produced to help understand how the study timeline is created
Image Modified View a representation of your study design in M11 format (warning draft development ongoing)
Image Modified Delete your Excel file from the server
Contact the CDISC USDM team if you have any questions on the Excel tool or if you are unsure how to represent certain study design information in the Excel tool
Vital signs- Adding timeline (demo'd at the follow-up webinar)
CDISC will be conducting workshops in the future to help users Master the USDM so keep a look out for workshops at PHUSE US Connect and the EU/US CDISC Interchanges.
link to orientation and examples
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.
Enter any review comments into JIRA - See instructions below
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)
See below for a detailed list of Public Review Comments
Provides more detail on Internal 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).
Expand
title
Click here to see a list of Public Review Comments
Ensure that the Project is set to "Digital Data Flow (DDF)"
Issue type will default to "Review Comments" - Please feel free to change the category if appropriate, otherwise it is fine to leave as "Review Comments".
In the Summary Box please enter a brief description of the comment
In the Components box please enter the standard to which you are commenting (USDM, API, CT)
Please leave the Fix Versions box empty
In the Description box please provide a thorough description of your comment.
This should be detailed enough for the CDISC DDF team to be able to clearly understand the intent of your comment in order to be able to action the comment.
Please also include any suggested changes with a rationale.
Please include any links to external material (if appropriate)
Please Enter "Internal Review" the Review Period box .
Please leave the Label box blank.
Click the
Status
title
CREATE
button
Note that if you want to create another JIRA issue please check the box near the create button
Once the JIRA issue is created you will see a confirmation message with a hyperlink to the JIRA issue
Warning
Please do not enter more than one issue into a JIRA ticket (unless they are closely related and need to be resolved together). This will ensure that we can link JIRA issues to future product backlog work.
This will allow access to see all the issues that you have created - you can click on the individual issue to see the details and make any edits required.
Localtab
title
Step 4 - Making Comments on Issues
In some instances the CDISC DDF team may request additional information - this can be done using the commenting feature within a JIRA issue.
Usually the CDISC team member will create a comment and tag people who they want to address their comment - This can be done by typing the "@" sign and then the JIRA username.
JIRA will notify you that there is a comment addressed to you from CDISC and a link to JIRA to open the JIRA ticket.
Comments are seen at the bottom of the JIRA ticket once it is open
You can reply to comments, add attachments, links etc.
This is often used to keep a record of the discussions used to resolve a JIRA ticket
