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The CDISC standards Development Process

The DDF Standards are now entering the public review commenting period after completing the standards development and internal review phases.

The purpose of the Public Review is to develop widespread consensus for the proposed standard by allowing for broad comment by the general public. Anyone interested may review and submit comments which must be reviewed and addressed by teams before proceeding to publication (CDISC-COP-001).


Public Review Timelines

The Public Review commenting period will be open for 30-days.

Public Review Commenting Start Date

Open Public Review Workshop

10-11am US Eastern

Join Zoom Meeting

(https://cdisc.zoom.us/j/94488548034?pwd=K0ZKakNObkZiNnk4U091ZHZmMGJmUT09&from=addon) 

Warning

Please add to your calendar as invites will not be sent


Public Review Commenting period closes

Public Review Webinar

A recording of the Public Review Webinar from 22nd March 2022 can be found here. It is recommended that you watch this recording to gain a deeper understanding of the materials that are being sent for Public Review. The Slide Deck used in the webinar is also available.

Webinar Summary

TopicPresenterTiming
Webinar IntroductionBernard Klinke00:00-06:51
CDISC and DDFDave Evans06:52-12:28

TransCelerate and DDF

Alison Luckman12:29- 22:17

CDISC DDF standards for public review

Dave Iberson-Hurst22:18-49:50
Public Review ProcessJohn Owen49:51-58:14

Q&A

All58:15

Review Materials

Note
  • Please be aware that some of the deliverables that are being developed may be out of your skill set.
  • The DDF review team is made up of experts in all the areas that the deliverables cover.
  • We appreciate any comments that you can provide that you feel you can provide input on.

As a guide to minimum review we have provided the following matrix based on Business SMEs and Technical Implementers

DeliverableBusiness SMETechnical Implementer
UML Diagram(tick)(tick)
API
(tick)
Controlled Terminology(tick)(tick)
Essential User Stories(tick)(tick)
Architectural Principles
(tick)


DeliverableCDISC StandardWhat would people ReviewFiles Available for Public ReviewFiles to download



Unified Study Definitions Model (USDM) Class Diagram



Yes

The UML class diagram (normative) as well as SQL Data Dictionary, Entity Relationship Diagram and example JSON output (informative)

Info
titleNeed some info on UML?

Refer to the supporting materials below


UML Class Diagram (.eapx and .png formats)




DDF CDISC RA Public Review - UML-Class-Diagram and Data Dictionary - 2021-03-28.zip

JSON Output (.json format)

ERD Diagram (.pgerd and .png formats)

SQL data dictionary (.sql format)

Java Docs (.zip)
API SpecificationYes

The API definition

JSON, HTML, YAML formats

DDF CDISC RA Public Review - API_for_DDF_2022-03-04.zip

Controlled TerminologyYes

The controlled terminology (normative) developed for the project

Excel format (for ease of searching and filtering)

DDF Controlled Terminology_Public Review_FINAL.xlsx

Essential User StoriesNoThe User StoriesPDF Document

2022 03 21 User Stories.pdf

Architecture PrinciplesNoThe architectural principles developed by the projectPDF Document

DDF CDISC RA GGG - Architecture_Principles - 2021-02-23.pdf

Supporting Materials - A set of informational materials in PDF format to help understand the deliverables being reviewed. 
Specific Public Review TopicsNo

Based on the remaining JIRA tickets a series of issues and questions the CDISC team would like input from public reviewers 

PDF document
  • Extract from JIRA tickets - feedback from Alison?
High-Level Model OverviewNo

Aid to reviewing the model

PDF Document
Technical NotesNo

Technical notes on Schedule of Activities and ODM/CRF creation

PDF Document
UML NotesNo

Help for those reading the UML diagrams

links

Using the DDF JIRA project to provide comments

  • All Public Review comments should be entered into the DDF JIRA Project as JIRA tickets.

  • You will need to log in or register for the CDISC Wiki to provide comments.  

    • Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.


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 choose "Public Review" in 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 wikijiraadmin@cdisc.org to help resolve
What should I do created a JIRA ticket by mistake

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

  • Please provide the JIRA ticket number