allowable appendix materials. will be withdrawn and not reviewed if they are determined to contain Appendix materials that are not specifically referenced in this notice or the FOA. N NIH, 1.0 Multi Y E New Rule Global Validation N Provide error if a At least one 0 AHRQ October Clinical Trial Study Clinical Trial 2017 If Yes to Human Record, or a Delayed Study = or Release “R" Subjects on Onset Study that is Record or a "I" Other Project marked as Delayed ‘Anticipated Note: This Information Clinical is not Onset Study Trial’, rule is form provided on the entire that is parallel to 034.5.5 for application for a FOA marked as Single Add New that is set to R or I, and ‘Anticipated Projects. Study/Delayed answered yes to Clinical Trial’ Onset Study on questions 1.4a through must be Human Subjects 1.4d provided. and Clinical Trial Information form
allowable appendix materials. will be withdrawn and not reviewed if they are determined to contain Appendix materials that are not specifically referenced in this notice or the FOA. Global Validation If Yes to Human Subjects on Other Project Information form Add New Study/Delayed Onset Study on Human Subjects and Clinical Trial Information form N N NIH, AHRQ 1.0 = “R" or "I" Multi Y Provide error if a Clinical Trial Study Record, or a Delayed Onset Study that is marked as ‘Anticipated Clinical Trial’, is not provided on the entire application for a FOA that is set to R or I, and answered yes to questions 1.4a through 1.4d At least one Clinical Trial Study Record or a Delayed Onset Study that is marked as ‘Anticipated Clinical Trial’ must be provided. E New Rule October 2017 Release Note: This rule is parallel to 034.5.5 for Single Projects. 0
eSub-validations-draft-07-12-2018.docx