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PHS 398 Cover Page Human Subjects Clinical Trial (Y/N) N N NIH, CDC, FDA, AHRQ, USU 4.0 and Both Both An answer is required if the answer to ‘Human Subjects Involved’ is "Yes" on the Other Project Information page. You must answer the “Clinical Trial?” question if you answer Yes to the “Are Human Subjects Involved?” question on the Other Project Information Form. E Forms D, March 2016 Release PHS 398 Cover Page Human Subjects Clinical Trial (Y/N) N N NIH, CDC, FDA, AHRQ, USU 4.0 and Both Both If Human Subjects Phase III Clinical Trial is true, Human Subjects Clinical Trial must be true You must answer Yes to the “Clinical Trial?” questions if you answer Yes to the “Agency-Defined Phase III Clinical Trial” question. E Forms D, March 2016 Release PHS 398 Cover Page Human Subjects Clinical Trial (Y/N) N N NIH, CDC, FDA, AHRQ, USU 4.0 and Multi Y If Human Subjects Clinical Trial is Yes on any component of the application and the Overall if Human Subjects Clinical Trial is No, provide Error The Human Subjects Clinical Trial question on the Overall Component must be marked as "Yes", in order for any Human Subjects Clinical Trial question in any component to be marked as "Yes". E PHS 398 Cover Page Human Subjects Clinical Trial (Y/N) N N NIH, CDC, FDA, AHRQ, USU 4.0 and Multi Y For New and Renewal applications, if Human Subjects Clinical Trial is No on all components of the application and Human Subjects Clinical Trial is Yes on the Overall, then provide Error. The Human Subjects Clinical Trial question must be ‘No’ on the Overall component, if the Human Subjects Clinical Trial question is ‘No’ for all other components in the application. E Defined all all
eSub-validations-draft-07-12-2018.docx