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 studies is since you did not 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 clinical trial? New Rule October 2017 Release PHS Section 034.8.70 N N NIH, 1.0 Excl: 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
Excl: Excl: October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an Phase III clinical trial? 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. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Is this an 034.8.70 N N NIH, 1.0 = “N”) AND ( to K12 Incl F’s: F05, F30, F31, F32, F33, F37, 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 E Study Record fields in Sections IV and V are blocked for F and K to Clinical Trial Not
eSub-validations-draft-10-10-2017.docx