are Clinical Product (IP) and Product (IP) and blocked Trial Investigational Investigational New 1.4d for New Drug Drug are studies 4.6a If (IND)/Investigational NOT which do yes, Device Device Exemption not describe Exemption (IDE) (IDE) status involve “Yes” the is attachment cannot clinical status” trials. provided. be provided since of you did not answer to questions “Yes” New 1.4.a-1.4.d in the Rule Product Clinical Trial October (IP) and Questionnaire. 2017 Release New Drug Device (IDE) status? PHS Section 034.8.67 N N NIH, 1.0 Excl: Provide error For study titled E Study “If Record Human yes, describe <study title> the – K12 fields in Subject the availability of Availability of Sections and Investigational Investigational IV and V Clinical Product (IP) and Product (IP) and = Incl are Trial Investigational Investigational New blocked “N”) F’s: New Drug Drug AND F05, for F and ( F30, K (IND)/Investigational F31,
Excl: Clinical Trial 4.6a If yes, describe the of Product (IP) and New Drug Device (IDE) status? 1.4d are NOT “Yes” Product (IP) and Investigational New Drug Device Exemption (IDE) status” is provided. Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status attachment cannot be provided since you did not answer “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. are blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.67 N N NIH, 1.0 = “N”) AND ( K12 Incl F’s: F05, F30, F31, Provide error “If yes, describe the availability of Investigational Product (IP) and Investigational New Drug For study titled <study title> the Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational E Study Record fields in Sections IV and V are blocked for F and K
eSub-validations-draft-07-12-2018.docx