October 2017 Release PHS Section 034.9.2 N N NIH, 1.0 Excl: Both Provide error if No more than 10 E Study Record Human 5 more than ten Clinical Trial-related – K12 fields in Subject Other Clinical attachment are Sections and Clinical allowed for Study IV and V Clinical Trial attachments are titled <study title> = are “R" Trial Related provided for the or required study "O") for AND studies involving to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release
Excl: October 2017 Release PHS Human Subject and Clinical Trial Section 5 – Other Clinical Trial Related 034.9.2 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error if more than ten Clinical attachments are provided for the study No more than 10 Clinical Trial-related attachment are allowed for Study titled <study title> E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule October 2017 Release
eSub-validations-draft-10-10-2017.docx