N N NIH, 1.0 Both E Study PHS Section 034.8.1 Provide error for For study titled Record Human a Clinical Trial <Study Title>, a brief – K12 fields in Subject Study Record if summary of the Sections and summary of the protocol must be IV and V Clinical protocol is not provided since you = are “R" Trial is provided. answered Yes to or required questions 1.4.a-1.4.d "O") for Brief AND studies in the Clinical Trial involving Questionnaire. to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.30 N N NIH, 1.0 Both Provide error for For study titled E Study to Record Human a Human <study title>, a brief – K12 fields in Subject Subject Study if summary of the Sections and Brief Summary protocol cannot be 1.4a IV and V Clinical of Protocol is provided since you are Trial is provided. did not answer Yes blocked to questions 1.4d for are in the Clinical studies NOT which do Trial Questionnaire. not
is is PHS Human Subject and Clinical Trial Section – Brief 034.8.1 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 summary of the protocol is not provided. For study titled <Study Title>, a brief summary of the protocol 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 Clinical Trial Section – 034.8.30 N N NIH, 1.0 to 1.4a 1.4d are NOT K12 Both Provide error for a Human Subject Study if Brief Summary of Protocol is provided. For study titled <study title>, a brief summary of the protocol 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
eSub-validations-draft-08-21-2017.docx