( F05, K 4.2.f Announcement does F30, Masking not allow to F31, to independent clinical F32, Clinical trials. F33, Trial Not 1.4a F37, Allowed F38, FOAs. FI2, 1.4d are ALL Incl New Rule K’s: October 2017 K05, Release K07, K08, K18, K22, K23, K26, K76, PHS Section 034.8.17 N N NIH, 1.0 Both Provide error for For study titled E Study Record Human a Study record <study title>, a – K12 fields in Subject if response to selection of either Sections and masking is Participant, Care IV and V Clinical but Provider, Investigator “Yes”, = are “R" Trial Participant, Care and/or Outcomes or required Provider, Assessor is required "O") for AND Investigator, if response to studies
4.2.f Masking ( to 1.4a 1.4d are ALL F05, F30, F31, F32, F33, F37, F38, FI2, Incl K’s: K05, K07, K08, K18, K22, K23, K26, K76, Announcement does not allow independent clinical trials. K to Clinical Trial Not Allowed FOAs. New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 034.8.17 N N NIH, 1.0 = “R" or "O") AND K12 Both Provide error for a Study record if response to masking is “Yes”, but Participant, Care Provider, Investigator, For study titled <study title>, a selection of either Participant, Care Provider, Investigator and/or Outcomes Assessor is required if response to E Study Record fields in Sections IV and V are required for studies
eSub-validations-draft-09-12-2017.docx