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 Clinical was selected for for“Other” = are “R" Trial Primary purpose Primary Purpose and or required is not provided you answered Yes to "O") for 4.2.b AND studies questions 1.4.a-1.4.d involving Primary in the Clinical Trial Purpose Questionnaire. to Other – clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS 034.8.33 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Section to Record Human a Human <study title>, a – K12 fields in Subject Subject Study if Primary Purpose or Sections and Primary purpose explanation for 1.4a IV and V Clinical or explanation Primary Purpose are Trial for Primary cannot be provided blocked since you did not 1.4d for
Excl: October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose – Other 034.8.4 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL Excl: D43, K12 Both Provide error for a Clinical Trial Study if an explanation for“Other” Primary purpose is not provided For study titled <Study Title>, an explanation is required if “Other” was selected for Primary Purpose and 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 – 034.8.33 N N NIH, 1.0 to 1.4a 1.4d K12 Both Provide error for a Human Subject Study if Primary purpose or explanation for Primary For study titled <study title>, a Primary Purpose or explanation for Primary Purpose cannot be provided since you did not E Study Record fields in Sections IV and V are blocked for
eSub-validations-draft-08-21-2017.docx