K07, New K08, Rule K18, October K22, 2017 K23, Release K26, PHS Section 034.8.25 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a Clinical Trial <study title> a – K12 fields in Subject Study if Participation ‘Subject Sections and Participation Duration is required IV and V Clinical is not since you answered Duration’ = are “R" Trial provided for the to questions “Yes” or required study 1.4.a-1.4.d in the "O") for 4.5 AND studies Clinical Trial involving Subject Questionnaire. to clinical Duration trials 1.4a (unless 1.4d = are I). ALL New Rule
Excl: K07, K08, K18, K22, K23, K26, New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.5 Subject Duration 034.8.25 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Clinical Trial Study if ‘Subject Participation Duration’ is not provided for the study For study titled <study title> a Participation Duration is required since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule
eSub-validations-draft-07-12-2018.docx