trials in the Clinical Trial 1.4a (unless Questionnaire. 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 Subject Subject Study if response to Sections and response to question, the “Will 1.4a IV and V Clinical question, study use an FDA “Will – are Trial the study use an regulated blocked FDA regulated cannot 1.4d for – intervention?” 4.6 Will are studies is be since you intervention?” “Yes”, NOT which do the did not answer “Yes” “Yes” not study to questions involve “Yes” use an in the Clinical clinical FDA Trial Questionnaire. – trials. New Rule October 2017 Release
Excl: 1.4a 1.4d are ALL in the Clinical Trial Questionnaire. trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.6 Will the study use an FDA – 034.8.64 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if response to question, “Will the study use an FDA – regulated intervention?” is “Yes” For study titled <study title> a response to question, “Will the study use an FDA – regulated intervention?” cannot be “Yes”, since you did not answer “Yes” to questions in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are blocked for studies which do not involve clinical trials. New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx