PHS Section 034.8.13 N N NIH, 1.0 Excl: Both Provide error for For study titled E New Rule Human a Study Record <study title>, – K12 October Subject when the response to the 2017 and response to the question "Is this an = Release Clinical question this NIH-defined Phase “Is “N Trial an NIH-Defined III clinical Trial Phase III Clinical cannot be "Yes" 4.2.d Is is since the FOA does Trial” “Yes” this an and the FOA not support Clinical does not support Trials. Clinical Trials. Phase III clinical trial? PHS Section 034.8.14 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study 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 Clinical Trial studies involving Questionnaire. to Model clinical trials 1.4a (unless
Excl: Excl: PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 034.8.13 N N NIH, 1.0 = “N K12 Both Provide error for a Study Record when the response to the question “Is this an NIH-Defined Phase III Clinical Trial” is “Yes” and the FOA does not support Clinical Trials. For study titled <study title>, response to the question "Is this an NIH-defined Phase III clinical Trial cannot be "Yes" since the FOA does not support Clinical Trials. E New Rule October 2017 Release 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 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
eSub-validations-draft-09-12-2017.docx