The CDISC standards Development Process
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 | (https://cdisc.zoom.us/j/94488548034?pwd=K0ZKakNObkZiNnk4U091ZHZmMGJmUT09&from=addon) 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
Topic | Presenter | Timing |
---|---|---|
Webinar Introduction | Bernard Klinke | 00:00-06:51 |
CDISC and DDF | Dave Evans | 06:52-12:28 |
TransCelerate and DDF | Alison Luckman | 12:29- 22:17 |
CDISC DDF standards for public review | Dave Iberson-Hurst | 22:18-49:50 |
Public Review Process | John Owen | 49:51-58:14 |
Q&A | All | 58:15 |
Review Materials
- 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.
Deliverable | CDISC Standard | What would people Review | Files Available for Public Review | Files to download |
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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) Need some info on UML? Refer to the supporting materials below | UML Class Diagram (.eapx and .png formats) | |
JSON Output (.json format) | ||||
ERD Diagram (.pgerd and .png formats) | ||||
SQL data dictionary (.sql format) | ||||
Java Docs (.zip) | ||||
API Specification | Yes | The API definition | JSON, HTML, YAML formats | |
Controlled Terminology | Yes | The controlled terminology (normative) developed for the project | Excel format (for ease of searching and filtering) | |
Essential User Stories | No | The User Stories | PDF Document | |
Architecture Principles | No | The architectural principles developed by the project | PDF Document | |
Supporting Materials - A set of informational materials in PDF format to help understand the deliverables being reviewed. | ||||
Specific Public Review Topics | No | Based on the remaining JIRA tickets a series of issues and questions the CDISC team would like input from public reviewers | PDF document |
|
High-Level Model Overview | No | Aid to reviewing the model | PDF Document |
|
Technical Notes | No | Technical notes on Schedule of Activities and ODM/CRF creation | PDF Document |
|
UML Notes | No | 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.