not = racial and ethnic Trial greater than categories must be Report “I” zero OR greater than zero "Comment" Ethnic must be provided Racial Total Count PHS Section 034.7.1 N N NIH, 1.0 Excl: Both Provide error if Protection of Human E New D43 , Subjects attachment Rule Human 3 Protection of – K12 is required for Study October Subject Human Subjects Record titled <study 2017 and and is not provided title> Release Clinical for a Study Trial Record Plans 3.1 of Human Subjects PHS Section 034.7.2 N N NIH, 1.0 Both Provide error if a A response to the E New question regarding Rule Human 3 response to the – K12 multi-site studies is October Subject question this “Is required for Study 2017 and and a multi-site Record titled <Study Release Clinical study that will Title>.
Trial Report Ethnic Racial Total Count not = “I” greater than zero OR "Comment" must be provided racial and ethnic categories must be greater than zero PHS Human Subject and Clinical Trial Section 3 – and Plans 3.1 of Human Subjects 034.7.1 N N NIH, 1.0 Excl: D43 , K12 Both Provide error if Protection of Human Subjects is not provided for a Study Record Protection of Human Subjects attachment is required for Study Record titled <study title> E New Rule October 2017 Release PHS Human Subject and Clinical Section 3 – and 034.7.2 N N NIH, 1.0 K12 Both Provide error if a response to the question “Is this a multi-site study that will A response to the question regarding multi-site studies is required for Study Record titled <Study Title>. E New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx