New clinical Rule trial? October 2017 Release PHS Section 034.8.70 N N NIH, 1.0 Excl: Provide error if For study titled E Study Record Human response to the <study title> a – K12 fields in Subject question this response to the “Is Sections and an NIH-defined question this an “Is Incl IV and V Clinical Phase III Clinical NIH-defined Phase = are F’s: Trial is III Clinical Trial” ”Yes” Trial?” blocked “N”) cannot be AND F05, for F and “Yes”, 4.2.d Is ( F30, K since this Funding F31, this an Opportunity to F32, to Announcement does F33, Clinical not allow F37, Trial Not Phase independent clinical 1.4a F38, Allowed III trials. FI2, FOAs. clinical 1.4d trial? are New ALL Incl Rule October K’s: 2017 Release K05, K07, K08, K18, K22, K23, K26,
Excl: clinical trial? New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 034.8.70 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, K26, Provide error if response to the question “Is this an NIH-defined Phase III Clinical Trial” is ”Yes” For study titled <study title> a response to the question “Is this an NIH-defined Phase III Clinical Trial?” cannot be “Yes”, since this 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-09-12-2017.docx