N N NIH, 1.0 Excl: Both Exemption number is E New PHS Section 034.5.2 Provide error if D43, required for Study Rule Human 1 Exemption – K12 Record <Study October Subject Basic number is not Title>, since you 2017 and provided when selected to the Release “Yes” Clinical response to “Is question this “Is Trial this Study Study Exempt from 1.3 Exempt from Federal Regulations” Federal is Regulations” number “Yes” PHS Section 034.5.6 N N NIH, 1.0 Both Provide error if Exemption 7 and/or New 8 are not valid Rule Human 1 Exemption 7 – selections for study October Subject Basic and/or 8 is USU title< study title> 2017 and selected on the Release Clinical Human Subject Trial Clinical Trial 1.3 form number 7 -8 PHS Section 034.5.3 N N NIH, 1.0 Excl: Both Provide error if You cannot answer E New D43, to questions Rule “Yes” Human 1 responses to – 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: Opportunity Announcement does
PHS Human Subject and Clinical Trial Section 1 – Basic 1.3 number 034.5.2 N N NIH, 1.0 Excl: D43, K12 Both Provide error if Exemption number is not provided when response to “Is this Study Exempt from Federal Regulations” is “Yes” Exemption number is required for Study Record <Study Title>, since you selected “Yes” to the question “Is this Study Exempt from Federal Regulations” E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 1 – Basic 1.3 number 7 -8 034.5.6 N N NIH, 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 034.5.3 N N NIH, 1.0 = “N” Excl: D43, K12 Excl F’s: Both Provide error if responses to questions 1.4.a through 1.4.d are “Yes”, but the Funding Opportunity You cannot answer “Yes” to questions 1.4a-1.4.d in the Clinical Trial Questionnaire since this Funding Opportunity Announcement does E New Rule October 2017 Release