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 studies in the Clinical Trial involving Masking Questionnaire. to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release N N NIH, 1.0 Both E Study PHS Section 034.8.46 Provide error for For study titled to Record Human a Study record if <study title> a – K12 fields in Subject response to response to the Sections and masking is masking question “Yes” 1.4a IV and V Clinical cannot be “Yes”, are Trial since you did not blocked answer to 1.4d for “Yes” are studies questions 1.4.a-1.4.d
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 ALL 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). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.46 N N NIH, 1.0 to 1.4a 1.4d are K12 Both Provide error for a Study record if response to masking is “Yes” For study titled <study title> a response to the masking question cannot be “Yes”, since you did not answer “Yes” to questions 1.4.a-1.4.d E Study Record fields in Sections IV and V are blocked for studies
eSub-validations-draft-10-10-2017.docx