New Rule October 2017 Release PHS Section 034.8.37 N N NIH, 1.0 Excl: Both Provide error for For study E Study to Record Human a Human titled<Study Title>, – K12 fields in Subject Subject Study if an intervention Sections and Intervention is cannot be provided 1.4a IV and V Clinical provided since you did not are Trial answer Yes to blocked questions 1.4d for 4.2.c are studies in the Clinical NOT which do Trial Questionnaire. not involve “Yes” clinical trials. New Rule October 2017 Release PHS Section 034.8.30 N N NIH, 1.0 Excl: Provide error if For study E Study Record Human Intervention is titled<Study Title> an – K12 fields in Subject provided intervention can not Sections and be provided since IV and V Clinical you did not answer = Incl are Trial Yes to questions blocked “N”) F’s: 1.4.a-1.4.d in the AND for F and ( F05, Clinical Trial K F30, Questionnaire. to F31, to
Excl: Excl: New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.c 034.8.37 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Intervention is provided For study titled<Study Title>, an intervention cannot be provided since you did not answer Yes to questions 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 Section – 034.8.30 N N NIH, 1.0 = “N”) AND ( to K12 Incl F’s: F05, F30, F31, Provide error if Intervention is provided For study titled<Study Title> an intervention can not 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 F and K to
eSub-validations-draft-08-21-2017.docx