are ALL New K’s: Rule October K05, 2017 K07, Release K08, K18, K22, K23, K26, PHS Section 034.8.27 N N NIH, 1.0 Excl: Both Provide error if For study titled E Study 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 “Will 1.4d Product use an
Excl: are ALL K’s: K05, K07, K08, K18, K22, K23, K26, New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.6a If yes, describe the of Product 034.8.27 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d 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 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 E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless
eSub-validations-draft-10-10-2017.docx