K22, K23, K26, PHS Section 034.8.26 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a Clinical Trial <study title>, A – K12 fields in Subject Study if response to the Sections and response to the question the “Will IV and V Clinical question, study use an FDA “Will – = are “R" Trial the study use an regulated or required FDA regulated is "O") for – intervention?” 4.6 Will AND studies intervention? is required since you involving the not provided. answered to “Yes” study questions 1.4.a-1.4.d to use an in the Clinical Trial clinical FDA Questionnaire. – trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release
Excl: K22, K23, K26, PHS Human Subject and Clinical Trial Section – 4.6 Will the study use an FDA – 034.8.26 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 if response to the question, “Will the study use an FDA – regulated intervention? is not provided. For study titled <study title>, A response to the question “Will the study use an FDA – regulated intervention?” is required 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
eSub-validations-draft-10-10-2017.docx