3.3 Data in the Clinical Trial and Questionnaire. to Safety Plan 1.4a 1.4d is ALL 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 and response to the question a Data “Will Release Clinical question a 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 Yes to questions study?” 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?
3.3 Data and Safety Plan to 1.4a 1.4d is ALL in the Clinical Trial Questionnaire. 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