Racial must be provided. Total PHS Section 034.6.15 N N NIH, 1.0 Excl: Both Provide warning For study titled W New D43, <study title>, IER Rule Human 2 if response to – K12 <number> you have Subject using an existing only included October and data set or is 2017 “unknown/not Clinical resource is not = counts for Release reported” Trial "Yes" and ONLY racial and ethnic “I” Report "Unknown/Not categories. Since you have selected Reported" to existing Ethnic “yes” greater than dataset or resource, zero cumulative you must indicate Racial counts are male and/or female provided. counts for these Total categories. 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 planned counts for
Racial Total must be provided. PHS Human Subject and Clinical Trial Section 2 – Report Ethnic Racial Total 034.6.15 N N NIH, 1.0 is not = “I” Excl: D43, K12 Both Provide warning if response to using an existing data set or resource is "Yes" and ONLY "Unknown/Not Reported" greater than zero cumulative counts are provided. For study titled <study title>, IER <number> you have only included “unknown/not reported” counts for racial and ethnic categories. Since you have selected “yes” to existing dataset or resource, you must indicate male and/or female counts for these categories. W New Rule October 2017 Release PHS Human Subject and Clinical Section 2 – 034.6.14 N N NIH, 1.0 is Excl: D43, K12 Both If "Using an Existing Dataset or Resource" is "No", "Planned Counts" must be For study titled <study title>, IER <number>, if not using an existing dataset or resource, planned counts for E New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx