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 October Subject Basic and/or 8 is 2017 and selected on the Release Clinical Human Subject Trial Clinical Trial USU 1.3 form and the response to the question, this “Is number study exempt 7 -8 from Federal Regulations is “Yes” PHS Section 034.5.3 N N NIH, 1.0 Excl: Both Provide error if You cannot answer E New D43, to 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”, this Funding “N”
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 and the response to the question, “Is this study exempt from Federal Regulations is “Yes” Exemption 7 and/or 8 are not valid selections New Rule October 2017 Release PHS Human Subject and Clinical Section 1 – Basic 034.5.3 N N NIH, 1.0 = “N” Excl: D43, K12 Both Provide error if responses to questions 1.4.a through 1.4.d are “Yes”, but You cannot answer “Yes” to questions 1.4a-1.4.d in the Clinical Trial Questionnaire since this Funding E New Rule October 2017 Release
eSub-validations-draft-09-12-2017.docx