to F32, to 4.6a If Device Device Exemption F33, Clinical yes, Exemption (IDE) (IDE) status F37, Trial Not describe is attachment cannot status” 1.4a F38, Allowed the provided. be provided since FI2, FOAs. the Funding of Opportunity 1.4d Announcement does are New ALL Incl Rule not allow October K’s: Product independent clinical 2017 (IP) and trials. Release K05, K07, New K08, Drug K18, K22, K23, Device K26, (IDE) status? PHS Section 034.8.28 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 Dissemination Plan Sections and is required since you “Dissemination IV and V Clinical answered to Plan” “Yes” = are “R" Trial attachment is questions 1.4.a-1.4.d or required not attached in the Clinical Trial "O") for 4.7 AND Questionnaire. studies involving to
Excl: 4.6a If yes, describe the of Product (IP) and New Drug Device (IDE) status? to 1.4a 1.4d are ALL F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, Device Exemption (IDE) status” is provided. Device Exemption (IDE) status attachment cannot be provided since the Funding Opportunity Announcement does not allow independent clinical trials. to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.7 034.8.28 N N NIH, 1.0 = “R" or "O") AND to K12 Both Provide error for a Clinical Trial study if “Dissemination Plan” attachment is not attached For study titled <study title> a Dissemination Plan is required since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving
eSub-validations-draft-07-12-2018.docx