FDA valication rules for SEND

Pinnacle 21 Support SEND
1

Hi William,

OpenCDISC validation checks will definetely cover SEND rules published on FDA website. Particular implementations details are still under discussion.

Kind Regards,

Sergiy Sirichenko / OpenCDISC team

2

Are you planning to create a validation rule set that matches the validation rules FDA published about Sept 4, 2013 for nonclinical dataset for submission to CDER? They can be found at the following site as the last bullet under 1.6:

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm