October 2017 Release PHS Section 034.8.33 N N NIH, 1.0 Both Provide error for For study titled E Study 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 Purpose is since you did not 1.4d for 4.2.b are studies provided. answer Yes to NOT which do Primary questions 1.4.a-1.4.d all not Purpose in the Clinical Trial involve “Yes” Questionnaire. clinical trials. New Rule October 2017 Release PHS 4.2.b 034.8.35 N N NIH, 1.0 Excl: Provide error if For study titled E Study Record Human Primary Primary Purpose <study title>, a K12 fields in Subject Purpose or explanation Primary Purpose or Sections and for Primary explanation for IV and V Clinical Purpose is Primary Purpose = Incl are Trial provided. cannot be provided blocked “N”) F’s: since this Funding AND for F and ( F05, Opportunity K F30, Announcement does to F31, to not allow F32, Clinical F33, Trial Not
Excl: October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose 034.8.33 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if Primary Purpose or explanation for Primary Purpose is provided. For study titled <study title>, a Primary Purpose or explanation for Primary Purpose cannot be provided since you did not answer Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial 4.2.b Primary Purpose 034.8.35 N N NIH, 1.0 = “N”) AND ( to K12 Incl F’s: F05, F30, F31, F32, F33, Provide error if Primary Purpose or explanation for Primary Purpose is provided. For study titled <study title>, a Primary Purpose or explanation for Primary Purpose cannot be provided since this Funding Opportunity Announcement does not allow E Study Record fields in Sections IV and V are blocked for F and K to Clinical Trial Not
eSub-validations-draft-10-10-2017.docx