N N NIH, 1.0 Excl: Both E Study PHS Section 034.8.43 Provide error for For study titled to Record Human a Human <study title>, an – K12 fields in Subject Subject Study if Intervention Model or Sections and Intervention description of 1.4a IV and V Clinical Model or Intervention Model are Trial description of cannot be provided blocked Intervention since you did not 1.4d for 4.2.e are studies Model is answer to “Yes” NOT which do provided. questions 1.4a not through 1.4d in the involve “Yes” Model Clinical Trial clinical Questionnaire. trials. New Rule October 2017 Release PHS Section 034.8.74 N N NIH, 1.0 Provide error if For study titled E Study Record Human Intervention <study title>, an – K12 fields in Subject Model or Intervention Model or Sections and description for description for Incl IV and V Clinical Intervention Intervention Model = are F’s: Trial Model is cannot be provided blocked “N”) provided since the Funding AND F05, for F and 4.2.e ( F30, Opportunity K F31, Announcement does to F32, to not allow F33, Clinical Model independent clinical F37, Trial Not trials 1.4a F38, Allowed FI2, FOAs. 1.4d
Excl: PHS Human Subject and Clinical Trial Section – 4.2.e Model 034.8.43 N N NIH, 1.0 to 1.4a 1.4d are NOT “Yes” K12 Both Provide error for a Human Subject Study if Intervention Model or description of Intervention Model is provided. For study titled <study title>, an Intervention Model or description of Intervention Model cannot be provided since you did not answer “Yes” to questions 1.4a through 1.4d 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 PHS Human Subject and Clinical Trial Section – 4.2.e Model 034.8.74 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Provide error if Intervention Model or description for Intervention Model is provided For study titled <study title>, an Intervention Model or description for Intervention Model cannot be provided since the Funding Opportunity Announcement does not allow independent clinical trials E Study Record fields in Sections IV and V are blocked for F and K to Clinical Trial Not Allowed FOAs.
eSub-validations-draft-07-12-2018.docx