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FDA valication rules for SEND
s
Sergiy
on September 13, 2013
Hi William, OpenCDISC
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
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: