2. CAC Meeting
Tuesday, 21 June, 2017

3. Key points – Standards Development
Optimize Standards Development and Release Process
more predictable and transparent development and maintenance process will be rolled out
Roll out Release Schedule/Versioning 1 November
Update COP Standards Development and develop COP- 019 Volunteer Engagement
Define new Technical Principles by 1 September
Roll out Volunteer training 1 October
Align standards development with SHARE
Seeing more re-use of concepts as we expand TA standards content – but also more complexity
Prodigious TA standard development output, while expanding the scope towards Beginning to End (B2E)

4. Development Activity Milestones
Production Releases
Standard
Release Date
SDTM v1.5
SENDIG v3.1
SENDIG-DART (Developmental and Reproductive Toxicology) *
Glossary v10
SDTMIG v3.2 Conformance Rules
Development Releases for Public Review
A number of standards have been released into production since the last year. Those standards are:
SDTM v1.5 that was released to support SENDIG v3.1, both of those standards were released in July 2016
SENDIG-DART is an implementation guide for developmental and reproductive toxicology studies, this standard is currently a provisional release but will be a formal production release soon. That will happen when SDTM version 1.6 is released, SDTM version 1.6 is currently out for public review. Changes in this version of SDTM include, exclusively, the additions to support SENDIG-DART
A new version of the CDISC Glossary was released in December It is six years since the glossary was last updated but the team is planning for an annual update going forward. Version 10 of the glossary provides definitions for Study Milestones, eSource, Transparency, and Clinical Trial & Clinical Study.
Standards released for public review include the CDASH Model version 1 and CDASHIG version 2.0, SDTM version 3.3 and Define-XML version 2.1
Standard
Review Date
CDASH Model v1.0 & CDASHIG v2.0
SDTMIG v3.3
Define-XML v2.1
* Provisional Release

5. Projects Animal Rule SEND
New Foundational standard being developed with C-PATH under an FDA grant from CTECS (Counter-Terrorism and Emergency Coordination Staff)
Hybrid of SENDIG and SDTMIG for studies where efficacy is assessed using animals
This will be a new product in the SEND family of standards
PhUSE SEND group providing SME support
SEND
SENDIG-DART – soon to be a final production version
SEND Confirmed Endpoints
Some interesting foundational standards projects to acknowledge started up in The Animal Rule project is developing an implementation guide for studies where human efficacy studies are not ethical and field trials are not feasible. These types of studies are looking at treatments or prophylaxis for conditions caused by exposure to lethal or permanently disabling toxic substances: chemical, biological, radiological, or nuclear substances. The resulting implementation guide will be released as a new product in the SEND family of standards but will essentially be a hybrid that contains content both from the SENDIG and the SDTMIG. These types of study are quite rare and CDISC is partnering with PhUSE to bring valuable subject matter expertise into the project. As mentioned previously, the SENDIG-DART will become a production standard once SDTM version 1.6 is released. The SEND team is also producing and informative document that will provide clarity on the types of study that can be confidently accommodated by SENDIG version 3.0

6. TA Program Status Optimize Standards Development and Release Process
Q217
Q217
Out for Public
Review
Q317
Q317
Q417
Q417
Q417
2018
Total of 30* TA Standards published (Pre-CFAST 6 | CFAST 24 (5th year))
New TA standards in development – 11
Optimize Standards Development and Release Process
more predictable and transparent development and maintenance process will be rolled out
Roll out Release Schedule/Versioning 1 November
Update COP Standards Development and develop COP- 019 Volunteer Engagement
Define new Technical Principles by 1 September
Roll out Volunteer training 1 October
Align standards development with SHARE
Seeing more re-use of concepts as we expand TA standards content – but also more complexity
Prodigious TA standard development output, while expanding the scope towards Beginning to End (B2E)
We will continue to develop high quality standards that respond to the needs of our community
2018
2018
2018
Stakeholder resourced  
Volunteer resourced

7. The following is a very rough draft proposal to address issues the community has raised for release frequency and versioning. Critiques, changes, queries all welcome.

8. DRAFT Phase 1: Scheduled Releases & Versioning
Ca. June 15
1st Friday, November
8-14 Months
Final Status, Release
120 Day Interval Can Occur Anytime Up to June 15
CDISC Review
Public Review
Final Stnds
PDFs or HTML
60 days
60+ days
This a draft release cycle to meet the needs of our community, where standards are released every 12 or 18 months. CDISC standards will be released once each year on the first Friday in November. To support this release, any standard that will be considered for release that year will must be packaged in mid-June. Teams can complete their development work either early in the release cycle or they can choose to wait until the next cycle to release their content. Where content is completed early, it will be tagged as reviewed but not yet finally released.
MRC
Development
Internal Review
SRC
Changes & Publication
Standards Dev.
Development
Internal Review
SRC
Changes & Publication
Development

9. Summary
Rationale - to establish a consistent release schedule for “Final” standards
“Provisional” status standards can be published when available as draft for trial use
Move from “Provisional” to ”Final” status according to new schedule