are Clinical but Investigator, and/or “Yes”, blocked Trial Participant, Care Outcomes Assessor 1.4d for Provider, cannot be selected are studies 4.2.f Investigator, since you did not NOT which do Masking Outcomes answer Yes to not Assessor is questions 1.4.a-1.4.d involve “Yes” selected. in the Clinical Trial clinical trials. Questionnaire. Care New Rule October 2017 Release PHS Section 034.8.38 N N NIH, 1.0 Excl: Provide error for For study titled E Study Record Human a Study Record <study title>, – K12 fields in 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
Excl: Clinical Trial 4.2.f Masking Care 1.4d are NOT “Yes” “Yes”, but Participant, Care Provider, Investigator, Outcomes Assessor is selected. Investigator, and/or Outcomes Assessor cannot be selected since you did not answer Yes to questions 1.4.a-1.4.d in the Clinical Trial Questionnaire. are blocked for studies which do not involve clinical trials. New Rule October 2017 Release PHS Human 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 K12 Incl F’s: F05, F30, F31, F32, F33, F37, F38, FI2, 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.
eSub-validations-draft-08-21-2017.docx