N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.27 Provide error if For study titled Record Human yes, describe <study title>, the – “If K12 fields in Subject the availability of Availability of Sections and Investigational Investigational IV and V Clinical Product (IP) and Product (IP) and = are “R" Trial Investigational Investigational New or required New Drug Drug "O") for 4.6a If AND studies (IND)/Investigational involving yes, Device Device Exemption describe Exemption (IDE) (IDE) status to the is not attachment must be status” clinical provided when provided since you trials of the response to answered to “Yes” 1.4a (unless the question questions 1.4.a-1.4.d the study in the Clinical Trial “Will 1.4d = Product use an Questionnaire. are I). (IP) and regulated ALL is intervention?” “Yes” New New Rule Drug October 2017 Release Device (IDE) status? PHS Section 034.8.66 N N NIH, 1.0 Excl: Both Provide For study titled E Study 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
Excl: Excl: regulated PHS Human Subject and Clinical Trial Section – 4.6a If yes, describe the of Product (IP) and New Drug Device (IDE) status? 034.8.27 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error if “If yes, describe the availability of Investigational Product (IP) and Investigational New Drug Device Exemption (IDE) status” is not provided when the response to the question “Will the study use an intervention?” is “Yes” For study titled <study title>, the Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status attachment must be provided since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Section – 034.8.66 N N NIH, 1.0 to 1.4a K12 Both Provide error“If yes, describe the availability of Investigational For study titled <study title>, the Availability of Investigational E Study Record fields in Sections IV and V
eSub-validations-draft-07-12-2018.docx