= are Trial masking is not answered Yes to “R" or required provided. questions 1.4.a-1.4.d "O") for in the Clinical Trial AND studies 4.2.f Questionnaire. involving Masking to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.46 N N NIH, 1.0 Both Provide error for For study titled E Study 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 Yes to 1.4d for 4.2.f are questions 1.4.a-1.4.d studies NOT which do Masking in the Clinical Trial all not Questionnaire. involve “Yes” clinical trials.
Trial 4.2.f Masking = “R" or "O") AND to 1.4a 1.4d are ALL masking is not provided. answered Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. are required for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.f Masking 034.8.46 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” 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 in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials.