K08, K18, K22, K23, K26, PHS Section 034.9.1 N N NIH, 1.0 ( Excl: Both Provide error if Study titled <study E Study Record Human 5 the study is NOT titled> is not a – K12 fields in Subject Clinical Trial and Clinical Trial and Other Sections and Clinical Other Clinical cannot have clinical IV and V Clinical Trial Trial-related trial-related = are Trial Related attachments are attachments. or blocked “N” provided. for “O” AND studies which do to not involve clinical 1.4a trials 1.4d are NOT all New “Yes” Rule October 2017 Release
Excl: K08, K18, K22, K23, K26, PHS Human Subject and Clinical Trial Section 5 – Other Clinical Trial Related 034.9.1 N N NIH, 1.0 ( = “N” or “O” AND to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error if the study is NOT Clinical Trial and Other Clinical Trial-related attachments are provided. Study titled <study titled> is not a Clinical Trial and cannot have clinical trial-related attachments. 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