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New FDA business rules for SDTM and SEND studies
s
Sergiy
on March 27, 2017
Here is a link to our…
Here is a link to our Webinar registration. You can also find it now as Ad in P21 Community tool.
http://us1.campaign-archive1.com/?u=f0426dd8503fac97a35223d50&id=268567ad84
s
Soeren
on May 22, 2018
FDA Validator Rules Dec 2017 v1.2 and SEND 3.1
Hi
- Could you please clarify the status of Pinnacle validator regarding FDA Validator Rules v1.2 released December 2017.
- If possible, I would also like to know, when Pinnacle is expecting to support SEND 3.1 validation?
Best regards
Soeren
s
Sergiy
on May 23, 2018
New FDA checks in the next release
Hi Soeren,
1. FDA Validator Rules v1.2 released December 2017 are already implemented in P21 Enterprise and will be available in the next release of P21 Community.
2. SEND IG 3.1 validation is also implemented a while ago. SEND 3.1 availability in Community version is still under discussion due to missing official checks published by CDISC and FDA.
Regards,
Sergiy
s
Soeren
on May 25, 2018
FDA Validator Rules Dec 2017 v1.2 and SEND 3.1
Hi Sergiy
Thanks for your reply. Any idea when next release of P21 Community will be available?
Søren
These rules will ensure that data is compliant, useful, and supports meaningful review and analysis. They also supplement the recently published CDISC conformance rules. How these rules will impact P21 users will be covered in our webinar - coming soon!
https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm2005545.htm