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 4.2.f AND studies Investigator, if response to involving Masking Outcomes masking is and “Yes” Assessor is not you answered “Yes” to selected. to questions clinical in the Clinical trials Care Trial Questionnaire. 1.4a (unless 1.4d = are I). ALL New Rule
K08, K18, K22, K23, K26, K76, PHS Human Subject and Clinical Trial Section – 4.2.f Masking Care 034.8.17 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error for a Study record if response to masking is “Yes”, but Participant, Care Provider, Investigator, Outcomes Assessor is not selected. For study titled <study title>, a selection of either Participant, Care Provider, Investigator and/or Outcomes Assessor is required if response to masking is “Yes” and you answered “Yes” to questions in the Clinical Trial Questionnaire. E Study Record fields in Sections IV and V are required for studies involving clinical trials (unless = I). New Rule
eSub-validations-draft-10-10-2017.docx