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 |
| Artefact | Location | Notes |
|---|---|---|
| USDM UML Logical Model |
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| USDM Controlled Terminology |
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| USDM API Specification |
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| 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
Other USDM Resources |
link to orientation and examples
Instructions for Public Review |
- 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.
- If readers are new to Digital Data Flow it is recommended to watch the video presentation on the TransCelerate DDF video library
- Of particular interest will be the video on the USDM Overview
- 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
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).
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 |
- 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 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
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.
- In the DDF JIRA Project click on the Issues Link
- 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.
- 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
| Question | Answer |
|---|---|
| What should I do if I can not access JIRA | Contact 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
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| 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
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