Sections Subject Subject Study if response to the 1.4a IV and V and response to the question this an “Is are Clinical question, this NIH-defined Phase “Is blocked Trial an NIH-defined III clinical Trial?” 1.4d for Phase III clinical cannot be “Yes”, are studies 4.2.d Is is since you did not trial?”, “Yes” NOT which do this an answer Yes to all not involve questions 1.4.a-1.4.d “Yes” clinical in the Clinical Trial trials. Phase Questionnaire. III clinical trial? New Rule October 2017 Release PHS Section 034.8.70 N N NIH, 1.0 Provide error if For study titled E Study Record Human response to the <study title> a – K12 fields in Subject question this response to the “Is Sections and an NIH-defined question this an “Is Incl IV and V Clinical Phase III Clinical NIH-defined Phase = are F’s: Trial is III Clinical Trial” ”Yes” Trial?” blocked “N”) cannot be AND F05, for F and “Yes”, 4.2.d Is ( F30, since this Funding K F31, this an Opportunity to F32, to Announcement does F33, Clinical not allow F37, Trial Not Phase independent clinical 1.4a F38, Allowed III trials. FI2, FOAs. clinical trial? 1.4d are New ALL Incl Rule
Subject and Clinical Trial 4.2.d Is this an Phase III clinical trial? 1.4a 1.4d are NOT all “Yes” Subject Study if response to the question, “Is this an NIH-defined Phase III clinical trial?”, is “Yes” 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. Sections IV and V are blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 034.8.70 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d are ALL K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl Provide error 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 this Funding Opportunity Announcement does not allow independent clinical trials. E Study Record fields in Sections IV and V are blocked for F and K to Clinical Trial Not Allowed FOAs. New Rule
eSub-validations-draft-08-21-2017.docx