Difference between revisions of "SEND Implementation User Group Minutes 2019-06-18"
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Latest revision as of 10:44, 18 June 2019
For other minutes, see the SEND Implementation User Group Minutes page.
Logistics
Meetings
Meetings occur every 4 weeks, at 1-2pm EDT.
Attendance
Participant | Attended |
---|---|
Troy Smyrnios | X |
Debra Oetzman | |
Audrey Walker | X |
Bill Houser | |
Brett Coupland | X |
Brian Argo | X |
Cheryl Sloan | |
Christy Kubin | |
Jason Rogers | |
Jeff Foy | |
Lou Ann Kramer | |
Mike Wasko | X |
Rick Thompson | X |
Rihab Kordane | |
Virginie Ora | X |
Wenxian Wang |
Minutes
Forum
Links:
- SEND Implementation Forum
- SEND Implementation News
- DISQUS Commenting - still open for business if you want to test things out
Review Forum
Current Issues
Open Issues
- Extending CT
- ACTION: next meeting, explore whether to add FAQ item or CT page about this
Review News Page
- Pinnacle 21 community item added
- Conformance rules item added
Wiki
- TS.xpt issue
- Links/text updated
- Added bit on TRC and callout to checklist
- eCTD / TRC links
- Links/text updated
- OPEN ITEMS
- TRC effective?
- Once TRC is actually published (officially), update any FAQ items mentioning "reject"
- TRC effective?
General
- SEND between Organizations SEND between Organizations
- LEFT OFF AT Can you provide lists of the mappings used to Controlled Terminology?
- SCOPE EXTENSION: Feedback
- FDA provides quarterly webinars
- Tabulating items from feedback
- Parse FDA webinar
- Content
- FDA Webinar
- will be posting them (but place unknown)
- FDA fit for use
- TCG feedback
- Encouragement/awareness to post freely when receiving this info
- Sponsor feedback
- Encouragement/awareness to post freely when receiving this info
- FDA Webinar
- Just more FAQ items - existing triage process is ok
- OPEN ITEMS*
- FDA Webinars
- where?
- FDA Webinars
Action Items
Responsible | Task | Timeframe |
---|---|---|
Troy | -- | Next meeting |
Last revision by Troy.smyrnios, 2019-06-18