PHS Section 034.6.9 N N NIH, 1.0 Excl: Both Provide error for Enrollment of First E New D43, Subject date is Rule Human 2 - a Human K12 required for study October Subject Study Subject and titled < Study Title>, 2017 and Clinical Trial and you must select Release Clinical study record if either Anticipated or 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 N N NIH, 1.0 Both An Inclusion E New S PHS Section 034.6.10 Provide error if 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
PHS Human Subject and Clinical Trial Section 2 - Study 2.8 of First Subject 034.6.9 N N NIH, 1.0 Excl: D43, K12 Both Provide error for a Human Subject and Clinical Trial study record if Enrollment of First Subject is not provided and the response to question 1.4a is "Yes". Enrollment of First Subject date is required for study titled < Study Title>, and you must select either Anticipated or Actual for enrollment of the first subject E New Rule 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 An Inclusion Enrollment Report is required for study tilted <Study Title>. E New Rule October 2017 Release
eSub-validations-draft-09-12-2017.docx