they are determined to contain Appendix materials that are not specifically referenced in this notice or the FOA. Global Validation N N NIH, 1.0 Multi Y Provide error if a At least one E New Rule 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 Information Clinical is not Onset Study Trial’, form provided on the entire that is application for a FOA marked as Add New that is set to R or I, and ‘Anticipated 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 Global Validation N N NIH, 1.0 Both Y Provide error if same Study E New Rule AHRQ October Study Record or Record and 2017 Human Subject Delayed Onset Study Delayed Release and Clinical title is duplicated in an Onset study Trial application. titles must Information be unique Note: Study Record and cannot and Delayed Onset be Study Record cannot duplicated in have the same titles
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 Global Validation Human Subject and Clinical Trial Information N N NIH, AHRQ 1.0 Both Y Provide error if same Study Record or Delayed Onset Study title is duplicated in an application. Note: Study Record and Delayed Onset Study Record cannot have the same titles Study Record and Delayed Onset study titles must be unique and cannot be duplicated in E New Rule October 2017 Release 0
eSub-validations-draft-10-10-2017.docx