"O") for Phase III Clinical required since you AND studies is not answered to Trial” “Yes” involving provided questions 1.4.a-1.4.d 4.2.d Is in the Clinical Trial to this an Questionnaire. clinical trials 1.4a (unless Phase III 1.4d = clinical are I). trial? ALL New Rule October 2017 Release PHS Section 034.8.42 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study to Record Human a Human <study title>, a – K12 fields in Subject Subject Study if response to the Sections and response to the question this an “Is 1.4a IV and V Clinical question, this NIH-defined Phase “Is are Trial an NIH-defined III Clinical Trial?” blocked Phase III clinical cannot be 1.4d for “Yes”, 4.2.d Is are is since you did not studies trial?”, “Yes” NOT which do this an answer to “Yes” all not questions 1.4.a-1.4.d involve “Yes” in the Clinical Trial clinical Phase Questionnaire. trials. III
Excl: 4.2.d Is this an Phase III clinical trial? "O") AND to 1.4a 1.4d are ALL Phase III Clinical Trial” is not provided required since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III 034.8.42 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if response to the question, “Is this an NIH-defined Phase III clinical trial?”, is “Yes” For study titled <study title>, a response to the question “Is this an NIH-defined Phase III Clinical Trial?” cannot be “Yes”, since you did not answer “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials.
eSub-validations-draft-07-12-2018.docx