Sections and Participation Duration IV and V Clinical is not is required since you Duration’ = are “R" Trial provided for the answered Yes to or required study questions 1.4.a-1.4.d "O") for 4.5 in the Clinical Trial AND studies Subject Questionnaire. involving to clinical Duration trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.62 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study to Record Human a Human <study title> a – K12 fields in Subject Subject Study if Subject Participation Sections and Subject Duration attachment 1.4a IV and V Clinical Participation and cannot be provided are Trial Duration is since you did not blocked provided answer Yes to 1.4d for 4.5 are questions 1.4.a-1.4.d studies NOT which do Subject in the Clinical Trial not Questionnaire. involve “Yes” clinical Duration trials.
Excl: and Clinical Trial 4.5 Subject Duration = “R" or "O") AND to 1.4a 1.4d are ALL Participation Duration’ is not provided for the study Duration is required since you answered Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. 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 – 4.5 Subject Duration 034.8.62 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Subject Participation and Duration is provided For study titled <study title> a Subject Participation Duration attachment cannot be provided 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.
eSub-validations-draft-08-21-2017.docx