Sections and Clinical Other Clinical cannot have clinical IV and V Clinical Trial Trial-related trial-related = are “N” Trial Related attachments are attachments. or blocked provided. for “O” AND studies which do to not involve clinical 1.4a trials 1.4d are NOT New “Yes” Rule 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
Excl: and Clinical Trial Clinical Trial Related = “N” or “O” AND to 1.4a 1.4d are NOT “Yes” Other Clinical Trial-related attachments are provided. cannot have clinical trial-related attachments. Sections IV and V are blocked for studies which do not involve clinical trials New Rule 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 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
eSub-validations-draft-09-12-2017.docx