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Localtab
titlePublic Review

Public Review Dates

Public Review Comment Period Start: Tuesday  

Public Review Comment Period End: Tuesday  

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

Info

Throughout the development process we have been using a visual representation to aid understanding of the UML model. The two files below represent the model at the end phase 1 (USDM v1.0) and at the end of phase 2 development. These two diagrams are intended to help the review audience see the differences between USDM v1.0 and USDM v2.0. Note that these files are for information only. The official normative content is represented in the UML file  above.

Public Review Webinar

Please sign up to the DDF2 Public Review Webinar to find out more information about the Public Review Version of the USDM. A recording of the webinar will be available here.


Note

Tool to see a visual view of a JSON file >> https://jsoncrack.com/editor

Internal Review USDM Deep Dive

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.

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)
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ystattypecomponents
chartTypetwodimensional
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xstattypestatuses
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 Internal 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