N N NIH, 1.0 Both E Study PHS Section 034.8.30 Provide error for For study titled to Record Human a Human <study title>, a brief – K12 fields in Subject Subject Study if summary of the Sections and Brief Summary protocol cannot be 1.4a IV and V Clinical of Protocol is provided since you are Trial is provided. did not answer blocked questions 1.4d for “Yes”to 4.1 Brief are studies 1.4.a-1.4.d in the NOT which do Clinical Trial all not Questionnaire. involve “Yes” clinical trials. New Rule October 2017 Release PHS Section 034.8.29 N N NIH, 1.0 Provide error if For study titled E Study Record Human Brief Summary <study title>, brief – K12 fields in Subject is provided summary of the Sections and protocol cannot be Incl IV and V Clinical provided since this = are F’s: Trial is Funding Opportunity blocked “N”) Announcement does AND F05, for F and 4.1 Brief ( F30, not allow K F31, independent clinical to F32, to trials. F33, Clinical F37, Trial Not 1.4a F38, Allowed FI2, FOAs. 1.4d
is is PHS Human Subject and Clinical Trial Section – 4.1 Brief 034.8.30 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if Brief Summary of Protocol is provided. For study titled <study title>, a brief summary of the protocol cannot be provided 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 – 4.1 Brief 034.8.29 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Provide error if Brief Summary is provided For study titled <study title>, brief summary of the protocol cannot be provided 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.
eSub-validations-draft-10-10-2017.docx