K26, PHS Section 034.8.26 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a Clinical Trial <study title> A – K12 fields in Subject Study if response to the Sections and response to the question the “Will IV and V Clinical question, study use an FDA “Will – = are “R" Trial the study use an regulated or required FDA regulated is "O") for – intervention?” 4.6 Will AND studies intervention? is required since you involving the not provided. answered Yes to study questions 1.4.a-1.4.d to use an in the Clinical Trial clinical FDA Questionnaire. – trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.64 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study to Record Human a Human <study title> a – K12 fields in
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eSub-validations-draft-08-21-2017.docx