trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.4 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study D43, Record Human a Clinical Trial <Study Title>, an – K12 fields in Subject Study if an explanation is Sections and explanation required if “Other” IV and V Clinical was selected for for“Other” = are “R" Trial Primary Purpose Primary Purpose and or required is not provided you answered "O") for “Yes” 4.2.b AND studies to questions involving Primary in the Clinical Purpose Trial Questionnaire. to Other – clinical trials 1.4a (unless 1.4d = are I). ALL New Rule
1.4a 1.4d are ALL trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose – Other 034.8.4 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL Excl: D43, K12 Both Provide error for a Clinical Trial Study if an explanation for“Other” Primary Purpose is not provided For study titled <Study Title>, an explanation is required if “Other” was selected for Primary Purpose and you answered “Yes” to questions 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