(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 CT study if <study title> a – K12 fields in Subject Dissemination Plan “Dissemination Sections and is required since you Plan” IV and V Clinical attachment is answered Yes to = are “R" Trial not attached questions 1.4.a-1.4.d or required in the Clinical Trial "O") for 4.7 AND studies Questionnaire. involving to Plan clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.68 Provide error for For study titled to Record Human a Human <study title> a – K12 fields in Subject Subject Study if Dissemination Plan Sections and Dissemination cannot be provided 1.4a IV and V Clinical Plan attachment since you did not are Trial is provided answer Yes to blocked questions 1.4.a-1.4.d 1.4d for are studies
Excl: Excl: (IDE) status? PHS Human Subject and Clinical Trial Section – 4.7 Plan 034.8.28 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a CT 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 clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.68 N N NIH, 1.0 to 1.4a 1.4d are K12 Both Provide error for a Human Subject Study if Dissemination Plan attachment is provided For study titled <study title> a Dissemination Plan cannot be provided since you did not answer Yes to questions 1.4.a-1.4.d E Study Record fields in Sections IV and V are blocked for studies
eSub-validations-draft-08-21-2017.docx