trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.30 N N NIH, 1.0 Both Provide error for For study titled E Study to Record Human a Human <study title>, a brief – K12 fields in Subject Subject Study if summary of the Sections and Brief Summary protocol cannot be 1.4a IV and V Clinical of Protocol is provided since you are Trial is provided. did not answer blocked questions 1.4d for “Yes”to 4.1 Brief are studies 1.4.a-1.4.d in the NOT which do Clinical Trial not Questionnaire. involve “Yes” clinical trials. New Rule October 2017 Release
is 1.4a 1.4d are ALL trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.1 Brief 034.8.30 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Brief Summary of Protocol is provided. For study titled <study title>, a brief summary of the protocol cannot be provided since you did not answer “Yes”to questions 1.4.a-1.4.d 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