October 2017 Release PHS Section 034.8.47 N N NIH, 1.0 Both Provide error for For study titled E Study to Record Human a Study Record <study title>, – K12 fields in Subject if response to Participant, Care Sections and masking is Provider, 1.4a IV and V Clinical but Investigator, and/or “Yes”, are Trial Participant, Care Outcomes Assessor blocked Provider, cannot be selected 1.4d for 4.2.f are studies Investigator, since you did not NOT which do Masking Outcomes answer to “Yes” all not Assessor is questions 1.4.a-1.4.d involve “Yes” selected. in the Clinical Trial clinical Questionnaire. trials. Care 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 ( F31, K Investigator, since the Funding F32,
October 2017 Release PHS Human Subject and Clinical Trial Section – 4.2.f Masking Care 034.8.47 N N NIH, 1.0 to 1.4a 1.4d are NOT all “Yes” K12 Both 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 you did not answer “Yes” to questions 1.4.a-1.4.d 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 – 034.8.38 N N NIH, 1.0 = “N”) AND ( K12 Incl F’s: F05, F30, F31, F32, Provide error for a Study Record if response to masking is “Yes”, but Participant, Care Provider, Investigator, For study titled <study title>, Participant, Care Provider, Investigator, and/or Outcomes Assessor cannot be selected since the Funding E Study Record fields in Sections IV and V are blocked for F and K
eSub-validations-draft-10-10-2017.docx