= are Clinical was selected for “R" for“Other” or required Trial Primary Purpose Primary Purpose and "O") for is not provided you answered “Yes” AND studies 4.2.b to questions involving Primary in the Clinical Purpose Trial Questionnaire. to Other – clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release PHS Section 034.8.33 N N NIH, 1.0 Both Provide error for For study titled E Study to Record Human a Human <study title>, a – K12 fields in Subject Subject Study if Primary Purpose or Sections and Primary Purpose explanation for 1.4a IV and V Clinical or explanation Primary Purpose are Trial for Primary cannot be provided blocked Purpose is since you did not 1.4d for 4.2.b are provided. answer Yes to studies NOT which do Primary questions 1.4.a-1.4.d all not Purpose in the Clinical Trial involve “Yes” Questionnaire. clinical trials.
Clinical Trial 4.2.b Primary Purpose – Other = “R" or "O") AND to 1.4a 1.4d are ALL for“Other” Primary Purpose is not provided was selected for Primary Purpose and you answered “Yes” to questions in the Clinical Trial Questionnaire. are required for studies involving clinical trials (unless = I). New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.b Primary Purpose 034.8.33 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both Provide error for a Human Subject Study if Primary Purpose or explanation for Primary Purpose is provided. For study titled <study title>, a Primary Purpose or explanation for Primary Purpose 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.
eSub-validations-draft-09-12-2017.docx