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News, Topics, Updates from the community:
- CDISC Core
- CDISC Library Browser
- NNIT (Study Developer?)
CDISC CORE is now available in a first Version with limited funtionality. Free access is possible for all Membership companies on this stage. In a later phase everybody can have free access to the System. More information on CDISC homepage (https://www.cdisc.org/core)
More information/Details about topics from thre IC might be shared once all presentations are available.
Pinnacle21 Webinar on May 18th
- Pinnacle Update (CDISC CORE Support)
Topic 2: New Googlegroups Mailling list,
Issues are reported from at least one meber that information was neither received via the old CDISC nor the new Googlegroups mailing list.
> Markus to investigate. If you have not received the meeting invite from the new group mailing list please send Markus an Email for further clarification.
Recommendation: Please add the email address cdisc-deun@googlegroups.com to your contacts to avoid it is getting filtered as spam.
Some information about the new mailing list...
Googlegroups CDISC DEUN Mitgliederliste
Hilfe/Info Googlegroups: https://support.google.com/groups#topic=9216
The new google mailing list is now in production and was already used by Kurt. For testing purposes Kurt has send the meeting invite of today's meeting to both mailing lists...
a) The existing (old) mailing list from CDISC: deun[at]lists.cdisc.org
b) The new mailing list: cdisc-deun[at]googlegroups.com
More information about how to join the group is mentioned on the CDISC DEUN wiki welcome page.
If the problem persist users should contact Markus for further investigation of the problem.
Communication should be send - at least for the time being - to both mailing lists until the new maling list has been tested accordingly.
Topic 3: Any other Business,
Discussion: All
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- Question: Death Details
Actual Death Date versus collected Date. Recommendation: Stick to SDM-IG, but if required it is also possible to add DDSTDTC to DD domain and collect actual Death Date in addition to DDDTC (Date/Time of Collection). Findings in P21 should be explained.
- FDA Workshop with DUKE on Safety Analysis
News on https://healthpolicy.duke.edu/events/advancing-premarket-safety-analytics - EMA CDISC Pilot launch
https://www.ema.europa.eu/en/news/ema-launches-pilot-project-analysis-raw-data-clinical-trials - New Googlegroups Mailling list
According to feedback from community in the TC all participants have received now the new meeting invitation details at least by the new googlegroups mailing-list.
No more missings are reported.
- Question: Death Details
Topic 2: AoB
Planning for 1st f-2-f meeting after COVID-19 pandemic
- Question: Users should reach out to their organisations/managers and ask whether travel in 2023 woudl be possible
- Mainanalytics has volunteered to host the meeting in case of
- Markus to contact Kurt and ask for TMF contact on registration support
- Question: Users should reach out to their organisations/managers and ask whether travel in 2023 woudl be possible
Next Meeting scheduled on Oct - 21th
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- Recommendation from team: to check the AP Implementation Guide and the protocol whether use of AP domains are indicated
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