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Trial Add New Report not = “I” study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected. PHS Human Subject and Clinical Trial Section 2 - Study Country 034.6.16 N N NIH, 1.0 is not = “I” K12 Both Provide error if same enrollment country is provided more than once For study titled <study title>, IER are selected more than once. E New Rule July 2018 Release PHS Human Subject and Clinical Trial Section 2 – Report Ethnic 034.6.13 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both If "Using an Existing Dataset or Resource" is "Yes", "Cumulative Counts" must be greater than zero OR "Comment" For study titled <study title>, IER <number>, if using an existing dataset or resource, cumulative counts for racial and ethnic categories must be greater than zero. E New Rule October 2017 Release >,