involving 4.2.f Outcomes masking is and “Yes” Masking Assessor is not you answered “Yes” to selected. to questions clinical in the Clinical trials Trial Questionnaire. 1.4a (unless Care 1.4d = are I). ALL New Rule 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 Investigator, since you did not studies 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
4.2.f Masking Care to 1.4a 1.4d are ALL Outcomes Assessor is not selected. masking is “Yes” and you answered “Yes” to questions in the Clinical Trial Questionnaire. involving clinical trials (unless = I). New Rule 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.
eSub-validations-draft-07-12-2018.docx