Incl blocked Trial Study Phase is since this Funding “N”) AND for F and F’s: provided Opportunity ( F05, K Announcement does F30, 4.2.d not allow to F31, to Study independent clinical F32, Clinical Phase Trials. F33, Trial Not 1.4a F37, Allowed F38, FOAs. FI2, 1.4d are ALL Incl New Rule K’s: October 2017 K05, Release K07, K08, K18, K22, K23, K26, K43, K38 PHS Section 034.8.12 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a Clinical Trial <study title> a – K12 fields in Subject study if response to the Sections and response to the question this an “Is IV and V Clinical question this NIH-defined Phase “Is = are “R" Trial an NIH-defined III Clinical is Trial?” or required
Excl: Trial 4.2.d Study Phase “N”) AND ( to 1.4a 1.4d are ALL Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, K43, K38 Study Phase is provided since this Funding Opportunity Announcement does not allow independent clinical Trials. blocked for F and K to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.12 N N NIH, 1.0 = “R" or K12 Both Provide error for a Clinical Trial study if response to the question “Is this an NIH-defined For study titled <study title> a response to the question “Is this an NIH-defined Phase III Clinical Trial?” is E Study Record fields in Sections IV and V are required
eSub-validations-draft-07-12-2018.docx