clinical trial? N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.14 Provide error for For study titled Record Human a Clinical Trial <Study Title>, an – K12 fields in Subject Study if Intervention Model Sections and Intervention must be provided IV and V Clinical model is not since you answered = are “R" Trial provided. to questions “Yes” or required 1.4.a-1.4.d in the "O") for 4.2.e AND studies Clinical Trial involving Questionnaire. to Model clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS 034.8.15 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Section 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
Excl: Excl: clinical trial? PHS Human Subject and Clinical Trial Section – 4.2.e Model 034.8.14 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 Intervention model is not provided. For study titled <Study Title>, an Intervention Model 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 – 034.8.15 N N NIH, 1.0 = “R" or K12 Both Provide error for a Clinical Trial Study if “Other” is selected as the Intervention Model and a For study titled <study title>, a description is required when “other” is selected as the Intervention E Study Record fields in Sections IV and V are required
eSub-validations-draft-10-10-2017.docx