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CDISC, in continued collaboration with TransCelerate’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.

Please direct any questions to John Owen  (jowen@cdisc.org)

Location of Materials for Public Review

ArtefactLocationNotes
USDM UML Logical Model
  • The public review version of the UML diagram is available on the USDM GitHub site
  • 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
USDM Controlled Terminology
  • The public review version of the Controlled Terminology (CT) is available on the USDM GitHub site



  • 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


USDM API Specification
  • The public review version of the API Specification is available on the USDM GitHub site
USDM Implementation Guide

The above information is also available as a single downloadable .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
Page properties
hiddentrue
  • The Public Review Webinar is available here (scroll to the end of page to access the recording).
  • Slides from the Public Review Webinar

Other USDM Resources

Dave Iberson-Hurst hosted a recorded USDM Deep Dive for Internal Review on Tuesday .

  • Please access the recording here.
  • Introductory slide deck here.
  • Chat with Q&A here
    • Link to the DDF Miro Board used in the deep dive (password = CDISC-DDF-SME)
  • Note that this is a living board - please refer to the date last updated on the first page
    • Please feel free to add stickies to this board if areas need additional explanation - Any comments related to the model should however be added as a JIRA issue.

    link to orientation and examples

    Instructions for Public Review

    1. It is recommended to familiarise yourself with the Digital Data Flow project by reading resources from  TransCelerate’s Digital Data Flow Project and CDISC's Digital Data Flow information.
      1. If readers are new to Digital Data Flow it is recommended to watch the video presentation on the TransCelerate DDF video library
      2. Of particular interest will be the video on the USDM Overview
    2. Download the Review Materials zip file from the link above.
      1. 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
      2. Navigate to each directory to see the deliverables
        1. API has both .yaml and .json formats
        2. 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.
        3. 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
        4. 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.
    3. Use the link above to navigate to the USDM Implementation Guide version on the WIKI.
      1. 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
    4. Perform your review
    5. 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)

    Jira Charts
    serverIssue Tracker (JIRA)
    sortDirection
    jqlproject%20%3D%20DDF%20AND%20created%20%3E%3D%202023-04-13%20AND%20created%20%3C%3D%202023-12-31%20ORDER%20BY%20created%20ASC%2C%20priority%20DESC%2C%20updated%20DESC%20%20%20%20
    ystattypecomponents
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    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45

    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
    titleClick here to see a list of Public Review Comments

    Jira
    serverIssue Tracker (JIRA)
    columnIdsissuekey,summary,issuetype,created,status,description,customfield_10500,customfield_10203
    columnskey,summary,type,created,status,description,CDISC Disposition Description,CDISC Disposition
    maximumIssues20
    jqlQueryproject = DDF AND created >= 2023-04-13 AND created <= 2023-12-31 ORDER BY created ASC, priority DESC
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45

    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 Instructions for Reviewers section of the USDM IG

    Instructions to create a JIRA comment for the UML, CT and API Deliverables

    Localtab Group
    tabStyleflat
    Localtab
    titleStep 1 - Open JIRA


    Localtab
    titleStep 2 - Create Ticket
    • In the create issue pop-up box
      • 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
      titleCREATE
       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.


    Localtab
    titleStep 3 - Review Your Tickets


    • Then Click the View all Issues Link

    • 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
    titleStep 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


    Localtab
    titleQ&A
    QuestionAnswer
    What should I do if I can not access JIRAContact jowen@cdisc.org to help resolve
    What should I do created a JIRA ticket by mistake

    Contact jowen@cdisc.org to request the JIRA ticket to be deleted

    • Please provide the JIRA ticket number
    What should I do if I created a JIRA ticket in the wrong project

    Contact jowen@cdisc.org to request the JIRA ticket to be deleted

    • Please provide the JIRA ticket number



    Localtab
    titlePublic Review