1.3 Federal is Regulations” “Yes” number PHS Section 034.5.6 N N NIH, 1.0 Both Provide error if Exemption 7 and/or New CDC, 8 are not valid Rule Human 1 Exemption 7 – FDA, selections for study October Subject Basic and/or 8 is title< study title> 2017 and selected on the Release Clinical Human Subject USU Trial Clinical Trial 1.3 form number 7 -8 N N NIH, 1.0 Excl: Both You cannot answer E New PHS Section 034.5.3 Provide error if D43, to all questions Rule Human 1 responses to “Yes” – K12 1.4a-1.4.d in the October Subject Basic questions 1.4.a Clinical Trial 2017 and through 1.4.d = Questionnaire since Release Clinical are but “Yes”, Excl this Funding “N” Trial the Funding Opportunity F’s: 1.4 Opportunity F05, Announcement does Clinical F30, not allow clinical Announcement F31, trials. Trial does not support F32, clinical trials. F33, F37, F38, 1.4.a – FI2, 1.4.d
1.3 number Federal Regulations” is “Yes” PHS Human Subject and Clinical Trial Section 1 – Basic 1.3 number 7 -8 034.5.6 N N NIH, CDC, FDA, USU 1.0 Both Provide error if Exemption 7 and/or 8 is selected on the Human Subject Clinical Trial form Exemption 7 and/or 8 are not valid selections for study title< study title> New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 1 – Basic 1.4 Clinical Trial 1.4.a – 1.4.d 034.5.3 N N NIH, 1.0 = “N” Excl: D43, K12 Excl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Both Provide error if responses to questions 1.4.a through 1.4.d are “Yes”, but the Funding Opportunity Announcement does not support clinical trials. You cannot answer “Yes” to all questions 1.4a-1.4.d in the Clinical Trial Questionnaire since this Funding Opportunity Announcement does not allow clinical trials. E New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx