are Incl New ALL Rule K’s: October K01, 2017 K02, Release K05, K07, K08, K18, K22, K23, K26, K76, PHS Section 034.8.16 N N NIH, 1.0 Both Provide error for For study titled E Study Record Human a study record if <study title> a – K12 fields in Subject response to response to the Sections and masking is not masking question is IV and V Clinical provided. required since you = are “R" Trial answered to “Yes” or required questions 1.4.a-1.4.d "O") for 4.2.f AND in the Clinical Trial studies involving Masking Questionnaire. to clinical trials 1.4a (unless 1.4d = are I).
are ALL Incl K’s: K01, K02, K05, K07, K08, K18, K22, K23, K26, K76, New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.f Masking 034.8.16 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are K12 Both Provide error for a study record if response to masking is not provided. For study titled <study title> a response to the masking question 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).
eSub-validations-draft-07-12-2018.docx