N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.25 Provide error for For study titled Record Human a Clinical Trial <study title> a – K12 fields in Study if Subject Participation ‘Subject 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 AND studies in the Clinical Trial involving Subject Questionnaire. 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 Study if Participation Sections and Duration attachment 1.4a IV and V Clinical Participation cannot be provided are Trial Duration is since you did not blocked provided answer to 1.4d “Yes” for 4.5 are questions 1.4.a-1.4.d studies NOT which do Subject in the Clinical Trial not Questionnaire. involve “Yes”
Excl: Excl: PHS Human and Clinical Trial Section – 4.5 Subject Duration 034.8.25 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Clinical Trial Study if ‘Subject Participation Duration’ is not provided for the study For study titled <study title> a Subject Participation Duration 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 and Clinical Trial Section – 4.5 Subject 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 Participation Duration is provided For study titled <study title> a 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
eSub-validations-draft-10-10-2017.docx