New Rule October 2017 Release PHS Section 034.8.38 N N NIH, 1.0 Provide error for For study titled E Study Record Human a Study Record <study title>, – K12 fields in Subject if response to Participant, Care Sections and masking is Provider, Incl IV and V Clinical but Investigator, and/or “Yes”, = are F’s: Trial Participant, Care Outcomes Assessor F05, blocked “N”) Provider, cannot be selected AND F30, for F and 4.2.f ( F31, K Investigator, since the Funding F32, Masking Outcomes Opportunity to F33, to Assessor is Announcement does F37, Clinical selected. not allow F38, Trial Not independent clinical 1.4a FI2, Allowed Care trials. FOAs. 1.4d are Incl ALL New K’s: Rule October K05, 2017 K07, Release K08, K18, K22, K23, K26, K76,
New Rule October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.f Masking Care 034.8.38 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, K08, K18, K22, K23, K26, K76, Provide error for a Study Record if response to masking is “Yes”, but Participant, Care Provider, Investigator, Outcomes Assessor is selected. For study titled <study title>, Participant, Care Provider, Investigator, and/or Outcomes Assessor cannot be selected 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. New Rule October 2017 Release
eSub-validations-draft-07-12-2018.docx