1.4d for study phase is did not answer “Yes” are studies provided. to questions 1.4a NOT which do through 1.4d in the not 4.2.d Clinical Trial involve “Yes” Study Questionnaire. clinical Phase trials. New Rule October 2017 Release PHS Section 034.8.56 N N NIH, 1.0 Excl: Provide error if For study titled E Study Record Human Study Phase or <study title>, a Study – K12 fields in Subject description for Phase or description Sections and Study Phase is for Study Phase IV and V Clinical provided cannot be provided = Incl are Trial since this Funding blocked “N”) F’s: Opportunity AND F05, for F and 4.2.d ( F30, K Announcement does F31, Study not allow to F32, to Phase independent clinical F33, Clinical Trials. F37, Trial Not 1.4a F38, Allowed FI2, FOAs. 1.4d are ALL Incl New K’s: Rule October K05, 2017 K07, Release
Excl: 4.2.d Study Phase 1.4d are NOT “Yes” study phase is provided. did not answer “Yes” to questions 1.4a through 1.4d in the Clinical Trial Questionnaire. for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.d Study Phase 034.8.56 N N NIH, 1.0 = “N”) AND ( to 1.4a 1.4d are ALL K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, Provide error if Study Phase or description for Study Phase is provided For study titled <study title>, a Study Phase or description for Study Phase cannot be provided since this 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. New Rule October 2017 Release
eSub-validations-draft-10-10-2017.docx