Cover Page Supplement Rule Categories to Activity to Form Field Validation Error Message Specific Lists Activity Code Multi (Lists & or or (Y/N) (Y/N) Both Both PHS 398 PD/PI Cover Page (prefix, first, middle, last, suffix) PHS 398 Human N N : Both Both An answer is You must answer the E Forms D, Cover Subjects NIH, 4.0 required if the March “Clinical Trial?” Page Clinical CDC, and answer to question if you answer 2016 Trial FDA, Subjects Yes to the Release ‘Human “Are (Y/N) AHRQ, is "Yes" Human Subjects Involved’ USU on the Other question on Involved?” Project the Other Project Information page. Information Form. PHS 398 Human N N Both Both If Human You must answer Yes E Forms D, Cover Subjects NIH, 4.0 Subjects to the March “Clinical Trial?” Page Clinical CDC, and Defined Phase III questions if you 2016 Trial FDA, Clinical Trial is answer Yes to the Release (Y/N) AHRQ, true, Human “Agency-Defined USU Subjects Clinical Phase III Clinical Trial” Trial must be true question. PHS 398 Human N N Incl Multi Y If Human The Human Subjects E Cover Subjects NIH, 4.0 all Subjects Clinical Clinical Trial question Page Clinical CDC, and Trial is Yes on on the Overall Trial FDA, any component of Component must be (Y/N) AHRQ, the application marked as "Yes", in USU and the Overall if order for any Human
Cover Page Supplement Form Field Rule Categories Validation Error Message (Y/N) (Y/N) (Lists Activity Specific Lists Activity Code & to Multi or Both to or Both PHS 398 Cover Page PD/PI (prefix, first, middle, last, suffix) 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 Incl 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 The Human Subjects Clinical Trial question on the Overall Component must be marked as "Yes", in order for any Human E Defined all
eSub-validations-draft-10-10-2017.docx