K08, K18, K22, K23, K26, PHS Section 034.8.19 N N NIH, 1.0 Both Provide error for For study titled E Study Record Human a Study Record <study title> at least – K12 fields in Subject if at least one one Outcome Sections and Outcome Measure is required IV and V Clinical Measure is not since you answered = are “R" Trial provided in the to questions “Yes” or required study. 1.4.a-1.4.d in the "O") for 4.3 AND studies Clinical Trial involving Questionnaire. to clinical trials 1.4a (unless 1.4d = are I). ALL New Rule
K08, K18, K22, K23, K26, PHS Human Subject and Clinical Trial Section – 4.3 034.8.19 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 at least one Outcome Measure is not provided in the study. For study titled <study title> at least one Outcome Measure is required since you answered “Yes” to questions 1.4.a-1.4.d 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-09-12-2017.docx