1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.15 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 description is “Other” Sections and is selected as required when IV and V Clinical the Intervention is selected as “other” = are “R" Trial Model and a the Intervention or required description for Model and you "O") for 4.2.e AND studies Other is not answered to “Yes” involving provided. questions 1.4.a-1.4.d in the Clinical Trial to Model Questionnaire. – clinical Other trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release
Excl: 1.4d are ALL = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.e Model – Other 034.8.15 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 “Other” is selected as the Intervention Model and a description for Other is not provided. For study titled <study title>, a description is required when “other” is selected as the Intervention Model and 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-09-12-2017.docx