New New is intervention?” Rule Drug “Yes” October 2017 Release Device (IDE) status? N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.66 Provide For study titled error“If to Record Human yes, describe <study title> the – K12 fields in Subject the availability of Availability of Sections and Investigational Investigational 1.4a IV and V Clinical Product (IP) and Product (IP) and are Trial Investigational Investigational New blocked New Drug Drug 1.4d for 4.6a If are studies (IND)/Investigational NOT which do yes, Device Device Exemption all not describe Exemption (IDE) (IDE) status involve “Yes” the is attachment cannot status” clinical provided. be provided since trials. of you did not answer Yes to questions New 1.4.a-1.4.d in the Rule Product Clinical Trial October (IP) and Questionnaire. 2017 Release New Drug
Excl: New Drug Device (IDE) status? intervention?” is “Yes” New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.6a If yes, describe the of Product (IP) and New Drug 034.8.66 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error“If yes, describe the availability of Investigational Product (IP) and Investigational New Drug Device Exemption (IDE) status” is provided. For study titled <study title> the Availability of Investigational 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. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials. New Rule October 2017 Release
eSub-validations-draft-08-21-2017.docx