ALL Incl New Rule K’s: October 2017 K05, Release K07, K08, K18, K22, K23, K26, K76, PHS Section 034.8.18 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a Study Record <study title> – K12 fields in Subject if allocation is Allocation is required Sections and not provided. since and you IV and V Clinical answered Yes to = are “R" Trial questions 1.4.a-1.4.d or required in the Clinical Trial "O") for 4.2.g AND studies Questionnaire. involving to clinical trials 1.4a (unless 1.4d = are I). ALL
Excl: ALL Incl K’s: K05, K07, K08, K18, K22, K23, K26, K76, New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.g 034.8.18 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Study Record if allocation is not provided. For study titled <study title> Allocation is required since and 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).
eSub-validations-draft-08-21-2017.docx