number selected. N N NIH, 1.0 Excl: Both For study titled E New PHS Section 034.6.13 If "Using an D43, <study title>, IER Rule Human 2 Existing Dataset – K12 <number>, if using October Subject or Resource" is an existing dataset 2017 and "Yes", is or resource, Release Clinical "Cumulative not = cumulative counts for Trial Counts" must be racial and ethnic “I” Report greater than categories must be greater than zero. zero OR Ethnic "Comment" must be Racial provided. Total PHS Section 034.6.14 N N NIH, 1.0 Excl: Both If "Using an For study titled E New D43, <study title>, IER Rule Human 2 Existing Dataset – K12 <number>, if not October Subject or Resource" is using an existing 2017 and "No", "Planned is dataset or resource, Release Clinical Counts" must be not = planned counts for Trial greater than racial and ethnic “I” Report zero OR categories must be greater than zero "Comment" Ethnic must be provided Racial
number selected. PHS Human Subject and Clinical Trial Section 2 – Report Ethnic Racial Total 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" must be provided. 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 PHS Human Subject and Clinical Trial Section 2 – Report Ethnic Racial 034.6.14 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both If "Using an Existing Dataset or Resource" is "No", "Planned Counts" must be greater than zero OR "Comment" must be provided For study titled <study title>, IER <number>, if not using an existing dataset or resource, planned counts for racial and ethnic categories must be greater than zero E New Rule October 2017 Release
eSub-validations-draft-09-12-2017.docx