titled < Study Title>, October and Clinical Trial and you must select 2017 Clinical study record if either Anticipated or Release Trial Enrollment of Actual for enrollment First Subject is of the first subject not provided and the response to question 1.4a is 2.8 "Yes". of First Subject S PHS Section 034.6.10 N N NIH, 1.0 Both Provide error if An Inclusion E New Enrollment Report is Rule Human 2 - Inclusion K12 required for study October Subject Study Enrollment tilted <Study Title>. 2017 and Report is not is Release Clinical provided and the not = Trial study is exempt “I” from federal regulations (1.2 Add is yes) and E4 is New not the only exemption Report number selected. PHS Section 034.6.13 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 using October Subject or Resource" is an existing dataset 2017 and "Yes", is or resource, Release
and Clinical Trial 2.8 of First Subject Clinical Trial study record if Enrollment of First Subject is not provided and the response to question 1.4a is "Yes". titled < Study Title>, and you must select either Anticipated or Actual for enrollment of the first subject October 2017 Release S PHS Human Subject and Clinical Trial Section 2 - Study Add New Report 034.6.10 N N NIH, 1.0 is not = “I” K12 Both Provide error if Inclusion Enrollment Report is not provided and the study is exempt from federal regulations (1.2 is yes) and E4 is not the only exemption number selected. An Inclusion Enrollment Report is required for study tilted <Study Title>. E New Rule October 2017 Release PHS Human Subject and Section 2 – 034.6.13 N N NIH, 1.0 is Excl: D43, K12 Both If "Using an Existing Dataset or Resource" is "Yes", For study titled <study title>, IER <number>, if using an existing dataset or resource, E New Rule October 2017 Release