Drug Device (IDE) status? PHS Section 034.8.67 N N NIH, 1.0 Excl: Provide error For study titled E Study “If Record Human yes, describe <study title> the – K12 fields in Subject the availability of Availability of Sections and Investigational Investigational IV and V Clinical Product (IP) and Product (IP) and = Incl are Trial Investigational Investigational New blocked “N”) F’s: New Drug Drug AND F05, for F and 4.6a If ( F30, K (IND)/Investigational F31, yes, Device Device Exemption to F32, to describe Exemption (IDE) (IDE) status F33, Clinical the is attachment cannot status” F37, Trial Not provided. be provided since 1.4a F38, Allowed of the Funding FI2, FOAs. Opportunity 1.4d Announcement does are New Product not allow ALL Incl Rule (IP) and independent clinical October K’s: trials. 2017 Release New K05, Drug K07, K08, K18, K22, K23,
Excl: Drug Device (IDE) status? PHS Human Subject and Clinical Trial Section – 4.6a If yes, describe the of Product (IP) and New Drug 034.8.67 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d are ALL K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, Provide error “If yes, describe the availability of Investigational Product (IP) and Investigational New Drug Device Exemption (IDE) status” is provided. For study titled <study title> the Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status attachment cannot be provided since the Funding Opportunity Announcement does not allow independent clinical trials. E Study Record fields in Sections IV and V are blocked for F and K to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release
eSub-validations-draft-10-10-2017.docx