New Rule October 2017 Release PHS Section 034.8.24 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 Study if Statistical Design Sections and Statistical and Power IV and V Clinical Design and is = are “R" Trial Power required since you or required is answered to "O") for “Yes” 4.4 AND studies not attached to questions 1.4.a-1.4.d involving the Study in the Clinical Trial Questionnaire. to Design clinical and trials Power 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.60 Provide error for For study titled to D43, Record Human a Human <study title> a – K12 fields in Subject Subject Study if Statistical Design Sections and Statistical and Power 1.4a IV and V Clinical Design and attachment cannot are
Excl: Excl: New Rule October 2017 Release PHS Human and Clinical Trial Section – 4.4 Design and Power 034.8.24 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Clinical Trial Study if Statistical Design and Power is not attached to the Study For study titled <study title>, a Statistical Design and Power 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 Section – 034.8.60 N N NIH, 1.0 to 1.4a K12 Both Provide error for a Human Subject Study if Statistical Design and For study titled <study title> a Statistical Design and Power attachment cannot E Study Record fields in Sections IV and V are D43,
eSub-validations-draft-07-12-2018.docx