N N NIH, 1.0 Both E Study PHS Section 034.8.19 Provide error for For study titled Record Human a Study Record <study title> at least – K12 fields in Subject if at least one one Outcome Sections and Outcome Measure is required IV and V Clinical Measure is not since you answered = are “R" Trial provided in the to questions “Yes” or required study. 1.4.a-1.4.d in the "O") for 4.3 AND studies Clinical Trial involving Questionnaire. to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.50 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study to Record Human a Human <study title>, an – K12 fields in Subject Subject Study if Outcome Measure Sections and an Outcome cannot be provided 1.4a IV and V Clinical Measure is since you did not are Trial provided answer to “Yes” blocked questions 1.4.a-1.4.d 1.4d for 4.3 are in the Clinical Trial studies NOT which do Questionnaire. not
Excl: PHS Human Subject and Clinical Trial Section – 4.3 034.8.19 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 at least one Outcome Measure is not provided in the study. For study titled <study title> at least one Outcome Measure 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 – 4.3 034.8.50 N N NIH, 1.0 to 1.4a 1.4d are NOT K12 Both Provide error for a Human Subject Study if an Outcome Measure is provided For study titled <study title>, an Outcome Measure 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
eSub-validations-draft-10-10-2017.docx