Sections Subject Subject Study if response to 1.4a IV and V and response to question, the “Will are Clinical question, study use an FDA “Will – blocked Trial the study use an regulated 1.4d for FDA regulated cannot – intervention?” are studies 4.6 Will is be since you intervention?” “Yes”, NOT which do the did not answer Yes all not “Yes” study involve to questions “Yes” clinical use an in the Clinical trials. FDA Trial Questionnaire. – New Rule October 2017 Release PHS Section 034.8.65 N N NIH, 1.0 Excl: Provide error if For study titled E Study 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
Excl: Subject and Clinical Trial 4.6 Will the study use an FDA – 1.4a 1.4d are NOT all “Yes” Subject Study if response to question, “Will the study use an FDA – regulated intervention?” is “Yes” response to question, “Will the study use an FDA – regulated intervention?” cannot be “Yes”, since you did not answer Yes to questions in the Clinical Trial Questionnaire. Sections IV and V are blocked for studies which do not involve clinical trials. New Rule October 2017 Release 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, 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.
eSub-validations-draft-08-21-2017.docx