Ethnic must be provided Racial Total PHS Section 034.6.15 N N NIH, 1.0 Excl: Both A comment is For study titled E New D43, <study title>, IER Rule Human 2 required if – K12 <number>, planned October Subject Planned or or cumulative counts 2017 and Cumlative greater than zero are Release Clinical Counts must be required, unless a Trial greater than comment is provided Report zero. indicating inclusion monitoring is conducted on another study or NIH grant N N NIH, 1.0 Excl: Both Protection of Human E New PHS Section 034.7.1 Provide error if D43 , Subjects attachment Rule Human 3 Protection of – K12 is required for Study October Subject Human Subjects Record titled <study 2017 and is not provided and title> Release Clinical for a Study Trial Record Plans 3.1 of
Ethnic Racial Total must be provided PHS Human Subject and Clinical Trial Section 2 – Report 034.6.15 N N NIH, 1.0 Excl: D43, K12 Both A comment is required if Planned or Cumlative Counts must be greater than zero. For study titled <study title>, IER <number>, planned or cumulative counts greater than zero are required, unless a comment is provided indicating inclusion monitoring is conducted on another study or NIH grant E New Rule October 2017 Release PHS Human Subject and Clinical Trial Section 3 – and Plans 3.1 of 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
eSub-validations-draft-08-21-2017.docx