New Rule October 2017 Release PHS Section 034.8.8 N N NIH 1.0 Excl: Both Provide error for For study E Study Record Human a Clinical Trial titled<Study Title>, – K12 fields in Subject Study if an Intervention Name Sections and Intervention must be provided IV and V Clinical Name is not since you answered = are “R" Trial provided to questions “Yes” or required 1.4.a-1.4.d in the "O") for 4.2.c AND studies Clinical Trial involving Questionnaire. to Name clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.10 N N NIH, 1.0 Excl: Both Provide error for For study titled E Study Record Human a Clinical Trial <study title> a Study – K12 fields in Subject Study if Study Phase is required Sections and Phase is not since you answered IV and V Clinical provided to questions “Yes” = are “R" Trial 1.4.a-1.4.d in the or required
Excl: Excl: New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.c Name 034.8.8 N N NIH 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Clinical Trial Study if an Intervention Name is not provided For study titled<Study Title>, Intervention Name must be provided since you answered “Yes” to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.10 N N NIH, 1.0 = “R" or K12 Both Provide error for a Clinical Trial Study if Study Phase is not provided For study titled <study title> a Study Phase is required since you answered “Yes” to questions 1.4.a-1.4.d in the E Study Record fields in Sections IV and V are required
eSub-validations-draft-09-12-2017.docx