PHS 034.8.20 N N NIH, 1.0 Excl: Both Provide error For study titled E Study D43, Record Human fora Clinical Trial <Study Title>, K12 fields in Study if an Outcome Measure Sections and Outcome subelement <Type, IV and V Clinical Measures Timeframe or = are “R" 4.3 Trial subelement Description> must be or required (type, provided since you "O") for AND studies timeframe, answered Yes to involving description) is questions 1.4.a-1.4.d in the Clinical Trial – not provided. to Type, Questionnaire. clinical trials 1.4a (unless 1.4d = are I). ALL New Rule October 2017 Release N N NIH, 1.0 Excl: Both E Study PHS 034.8.52 Provide error for For study titled to Record Human a Human <Study Title>, K12 fields in Subject Subject Study if Outcome Measure Sections and an Outcome subelement <Type, 1.4a IV and V Clinical Measures Timeframe or are 4.3 Trial subelement Description> cannot blocked (type, be provided for 1.4d for are studies timeframe, Outcome Measure
Excl: Excl: PHS Human and Clinical Trial 4.3 – Type, 034.8.20 N N NIH, 1.0 = “R" or "O") AND to 1.4a 1.4d are ALL K12 Both Provide error fora Clinical Trial Study if an Outcome Measures subelement (type, timeframe, description) is not provided. For study titled <Study Title>, Outcome Measure subelement <Type, Timeframe or Description> must be provided 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 October 2017 Release PHS Human Subject and Clinical Trial 4.3 034.8.52 N N NIH, 1.0 to 1.4a 1.4d are K12 Both Provide error for a Human Subject Study if an Outcome Measures subelement (type, timeframe, For study titled <Study Title>, Outcome Measure subelement <Type, Timeframe or Description> cannot be provided for Outcome Measure E Study Record fields in Sections IV and V are blocked for studies D43,
eSub-validations-draft-08-21-2017.docx