Trial Onset is Study not provided. PHS Section 034.5.2 N N NIH, 1.0 Excl: Both Provide error if Exemption number is E New D43, required for Study Rule Human 1 Exemption – K12 Record <Study Title> October Subject Basic number is not since you selected 2017 and provided when to the question Release “Yes” Clinical response to “Is this Study Exempt “Is Trial this Study from Federal 1.3 Exempt from Regulations” Federal is Regulations” number “Yes” PHS Section 034.5.3 N N NIH, 1.0 Excl: Both Provide error if You cannot answer E New D43, Yes to questions Rule 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: 1.4 Opportunity F05, Announcement does Clinical F30, not allow clinical Announcement F31, trials. Trial does not support F32, Clinical Trials. F33, F37, F38, FI2,
Trial Onset Study is not provided. 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 1.4 Clinical Trial 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 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-08-21-2017.docx