New FDA business rules for SDTM and SEND studies

Pinnacle 21 General News
1

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

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2

https://www.youtube.com/watch?v=pZ9YTdldQkk

3

Hi

  1. Could you please clarify the status of Pinnacle validator regarding FDA Validator Rules v1.2 released December 2017.
  2. If possible, I would also like to know, when Pinnacle is expecting to support SEND 3.1 validation?

Best regards

Soeren

4

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

5

Hi Sergiy

Thanks for your reply. Any idea when next release of P21 Community will be available?

Søren

6

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