FDA Business rules/ Pinnacle Validation rules

June 10, 2017

Hi Team,

I have questions regarding FDA business rules:

1.) Does Pinnacle 21 Community Version 2.2 checks for latest FDA business rules? To be more vivid configurations we choose from the Pinnacle, some has FDA in the (), does it mean FDA business rules are considered as well?   

2.) FDA ID present in validator are they obtained from FDA or they created by Pinnacle? 

In 2017 release of FDA business rules I see that FDA ID

  1. FDAB014”- Category for Disposition Event (DSCAT) should be populated. The identical rule is present in Pinnacle validation rules with different FDA IDFDAC203” -Category for Disposition Event (DSCAT) should be populated. Does Pinnacle needs an update? Please help me understand how these situations are handled. Thanks in advance.

Thanks,

Sai Krishna.

Hi Sai Krishna, 

Yes, current P21 checks need an update. P21 Community v2.2.0 was released in 2016. New FDA business rules were published in March, 2017.

Kind Regards, 

Sergiy  

Hi Sergiy,

Thanks for the reply. So these FDA validator rule ID's are they from FDA or Pinnacle creates them? I didn't find those rule id's nowhere in FDA older releases of validator rules. Please correct me if I am mistaken.

Thanks,

Sai Krishna.

 

Hi Kent,

FDA and new CDISC SDTM rules will be available in new BETA release this fall and finalized by the end of this year.

All official FDA, PMDA and CDISC rules will be available in both P21 Enterprise and Community versions.

Kind Regards, 

Sergiy