N N NIH, 1.0 Excl: E Study PHS Section 034.8.65 Provide error if For study titled Record Human response to <study title> a – K12 fields in Subject question, response to the “Will Sections and the study use an question the “Will IV and V Clinical FDA regulated study use an FDA – – = Incl are Trial is regulated intervention?” blocked “N”) F’s: cannot AND F05, for F and “Yes” intervention?” 4.6 Will ( F30, K be since the “Yes”, F31, the Funding Opportunity to F32, to study Announcement does F33, Clinical use an not allow F37, Trial Not FDA independent clinical – 1.4a F38, Allowed trials. FI2, FOAs. 1.4d are ALL New K’s: Rule October K05, 2017 K07, Release K08, K18, K22, K23, K26,
Excl: PHS Human Subject and Clinical Trial Section – 4.6 Will the study use an FDA – 034.8.65 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, K’s: K05, K07, K08, K18, K22, K23, K26, Provide error if response to question, “Will the study use an FDA – regulated intervention?” is “Yes” For study titled <study title> a response to the question “Will the study use an FDA – regulated intervention?” cannot be “Yes”, 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-07-12-2018.docx