New K05, Rule K07, October K08, 2017 K18, Release 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 Other Clinical Trial and Clinical Trial and 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
Excl: K05, K07, K08, K18, K22, K23, K26, New Rule October 2017 Release 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 “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
eSub-validations-draft-10-10-2017.docx