PHS Section 034.7.6 N N NIH, 1.0 Both Provide error for For study titled E New Rule Human 3 a Clinical Trial <Study Title>, a – K12 October Subject Study Record if response to the 2017 and response to the question, a and “Will Release Clinical question a Data and Safety “Will = “R" Trial Data and Safety Monitoring Board be or Plans Monitoring appointed for this "O") AND Board be is required study?” 3.4 Will appointed for since you answered a Data this is to questions study?” “Yes” to and not provided. 1.4.a-1.4.d in the Safety Clinical Trial Questionnaire. 1.4a Board 1.4d be is ALL for this study? PHS Section 034.8.1 N N NIH, 1.0 Both Provide error for For study titled E Study Record Human a Clinical Trial <Study Title>, a brief – K12 fields in Subject Study Record if summary of the Sections and summary of the protocol must be IV and V Clinical protocol is not provided since you = are “R" Trial is provided. answered to “Yes” or required questions 1.4.a-1.4.d "O") for Brief AND in the Clinical Trial studies involving Questionnaire. to clinical
is PHS Human Subject and Clinical Trial Section 3 – and Plans 3.4 Will a Data and Safety Board be for this study? 034.7.6 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d is ALL K12 Both Provide error for a Clinical Trial Study Record if response to the question “Will a Data and Safety Monitoring Board be appointed for this study?” is not provided. For study titled <Study Title>, a response to the question, “Will a Data and Safety Monitoring Board be appointed for this study?” is required since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – Brief 034.8.1 N N NIH, 1.0 = “R" or "O") AND to K12 Both Provide error for a Clinical Trial Study Record if summary of the protocol is not provided. For study titled <Study Title>, a brief summary of the protocol must be provided 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
eSub-validations-draft-07-12-2018.docx