"O") for Clinical Trial AND studies Questionnaire. involving 4.2.d to Study clinical Phase trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.11 N N NIH, 1.0 Excl: Both Provide error if For study titled E Study Record Human Study <study title> a – “Other” K12 fields in Subject Phase is Description is Sections and selected but required if is “Other” IV and V Clinical description for selected as the = are “R" Trial Study Study Phase and “Other” or required phase is not you answered Yes to "O") for 4.2.d AND studies provided questions 1.4.a-1.4.d involving Study in the Clinical Trial Phase Questionnaire. – to Other clinical trials 1.4a (unless 1.4d
Excl: 4.2.d Study Phase "O") AND to 1.4a 1.4d are ALL Clinical Trial Questionnaire. for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Study Phase – Other 034.8.11 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d K12 Both Provide error if “Other” Study Phase is selected but description for “Other” Study phase is not provided For study titled <study title> a Description is required if “Other” is selected as the Study Phase and 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
eSub-validations-draft-09-12-2017.docx