to ascertain if the inclusion of appendix material is permitted. Applications may be withdrawn and not reviewed if they contain appendix materials that are not specifically referenced in the notice or FOA. If Yes to Human N N NIH, 1.0 Multi Y Provide error if a At least one E New Rule 0 AHRQ October Subjects on Clinical Trial Study Clinical Trial 2017 Other Project Record, or a Delayed Study = or Release “R" Information Onset Study that is Record or a "I" form marked as Delayed ‘Anticipated Clinical is not Onset Study Trial’, Add New provided on the entire that is Study/Delayed application for a marked as Onset Study on FOAthat is set to R or ‘Anticipated Human Subjects I, and answered yes to Clinical Trial’ and Clinical Trial questions 1.4a through must be Information form 1.4d provided.
to ascertain if the inclusion of appendix material is permitted. Applications may be withdrawn and not reviewed if they contain appendix materials that are not specifically referenced in the notice or FOA. 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 FOAthat 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 0
eSub-validations-draft-08-21-2017.docx