PUBLIC REVIEW COMMENTING FOR DDF PHASE I IS NOW CLOSED |
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).
- Additional information on the overall aims of the DDF project can be found on the TransCelerate DDF Website and the CDISC DDF Website
- Additional information is available in the TransCelerate press release about the DDF project
Public Review Timelines |
| Public Review Commenting Start Date | ||
|---|---|---|
| Open Public Review Workshop | 10-11am US Eastern |
|
| 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 |
As a guide to minimum review we have provided the following matrix based on Business SMEs and Technical Implementers
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| Deliverable | CDISC Standard | What would people Review | Files Available for Public Review | Files 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)
| UML Class Diagram (.eapx and .png formats) | DDF CDISC RA Public Review - UML-Class-Diagram and Data Dictionary - 2022-04-04.zip
| ||
JSON Output (.json format) | ||||||
ERD Diagram (.pgerd and .png formats) ERD Overlay (.png format) - This is the ERD with overlay to help navigate the model and find classes quickly | ||||||
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 | |||
Updated to better organise the ERD and also provide an overlay of the ERD to better see the classes 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.
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