K08, K18, K22, K23, K26, K43, K38 PHS Section 034.8.12 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 this an “Is IV and V Clinical question this NIH-defined Phase “Is = are “R" Trial an NIH-defined III Clinical is Trial?” or required Phase III Clinical required since you "O") for 4.2.d Is AND studies is not answered to Trial” “Yes” involving this an provided questions 1.4.a-1.4.d in the Clinical Trial to Questionnaire. clinical Phase trials III 1.4a (unless clinical trial? 1.4d = are I). ALL New Rule
Excl: K08, K18, K22, K23, K26, K43, K38 PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 034.8.12 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 “Is this an NIH-defined Phase III Clinical Trial” is not provided For study titled <study title> a response to the question “Is this an NIH-defined Phase III Clinical Trial?” 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
eSub-validations-draft-10-10-2017.docx