K26, PHS Section 034.8.3 N N NIH, 1.0 Both Provide error for For study titled E Study Record Human a Clinical Trial <Study Title>, a – K12 fields in Subject Study Record if Primary Purpose Sections and Primary Purpose must be provided IV and V Clinical is not provided since you answered = are “R" Trial Yes to questions or required 1.4.a-1.4.d in the "O") for 4.2.b AND studies Clinical Trial involving Primary Questionnaire Purpose to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.4 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study D43, Record Human a Clinical Trial <Study Title>, an – K12 fields in Subject Study if an explanation is Sections and explanation required if “Other” IV and V
K26, PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose 034.8.3 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 Record if Primary Purpose is not provided For study titled <Study Title>, a Primary Purpose must be provided 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 Section – 034.8.4 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Clinical Trial Study if an explanation For study titled <Study Title>, an explanation is required if “Other” E Study Record fields in Sections IV and V
eSub-validations-draft-07-12-2018.docx