Sections Subject Phase is Description is IV and V and selected but required if is “Other” = are “R" Clinical description for selected as the or required Trial Study Study Phase and “Other” "O") for phase is not you answered Yes to AND studies 4.2.d provided questions 1.4.a-1.4.d involving Study in the Clinical Trial Phase to Questionnaire. – clinical Other trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.39 Provide error for For study titled to Record Human a Human <study title>, a study – K12 fields in Subject Subject Study if phase or a Sections and Study Phase or description for study 1.4a IV and V Clinical description for phase cannot be are Trial study phase is provided since you blocked provided. did not answer Yes 1.4d for 4.2.d are to questions 1.4a studies NOT which do Study through 1.4d in the not Phase Clinical Trial involve “Yes” Questionnaire.
Excl: Subject and Clinical Trial 4.2.d Study Phase – Other = “R" or "O") AND to 1.4a 1.4d are ALL Phase is selected but description for “Other” Study phase is not provided Description is required if “Other” is selected as the Study Phase and you answered Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. 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 – 4.2.d Study Phase 034.8.39 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Study Phase or description for study phase is provided. For study titled <study title>, a study phase or a description for study phase cannot be provided since you did not answer Yes to questions 1.4a through 1.4d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve
eSub-validations-draft-08-21-2017.docx