AHRQ, USU 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 “Agency-Defined Page CDC, and answer to Phase III Clinical 2016 Trial” Defined FDA, Subjects question if you answer Release ‘Human Phase III AHRQ, Clinical is Yes to the Trial’ “Clinical Clinical USU "Yes". question. Trial?” Trial (Y/N) PHS 398 Human N N Both Both If Human You cannot answer E Forms D, Cover Subjects NIH, 4.0 Subjects Clinical Yes to the March Page CDC, and Trial is No, this Phase III 2016 Defined FDA, cannot be equal Clinical Release Trial”question Phase III AHRQ, to Yes. if you anser No to the Clinical USU “Clinical Trial?” Trial question (Y/N) PHS 398 Human N Multi Y If NIH-Defined The NIH-Defined E Cover Subjects NIH, 4.0 all Phase III Clinical Phase III Clinical Trial Page CDC, and Trial is Yes on question on the Defined FDA, any component of Overall component Phase III AHRQ, the application must be marked as Clinical USU and the Overall if "Yes", in order for any Trial NIH-Defined NIH-Defined Phase III (Y/N) Phase III Clinical Clinical Trial question Trial is No, in any other provide Error component to be marked as "Yes". PHS 398 Human N Multi Y For New and The NIH-Defined E Cover Subjects NIH, 4.0 all Renewal Phase III Clinical Trial Page CDC, and applications, if question must be ‘No’ FDA, NIH Clinical Trial on the Overall Phase III AHRQ, is Yes and component, if Clinical USU Phase III Phase III Trial Clinical Trial is Clinical Trial question (Y/N) not on all ‘Yes’ components of is for all other ‘No’ the application and NIH-Defined
AHRQ, USU PHS 398 Cover Page Human Subjects Phase III 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 Clinical Trial’ is "Yes". You must answer the “Agency-Defined Phase III Clinical Trial” question if you answer Yes to the “Clinical Trial?” question. E Forms D, March 2016 Release PHS 398 Cover Page Human Subjects Phase III Clinical Trial (Y/N) N N NIH, CDC, FDA, AHRQ, USU 4.0 and Both Both If Human Subjects Clinical Trial is No, this cannot be equal to Yes. You cannot answer Yes to the Phase III Clinical Trial”question if you anser No to the “Clinical Trial?” question E Forms D, March 2016 Release PHS 398 Cover Page Human Subjects Phase III Clinical Trial (Y/N) N NIH, CDC, FDA, AHRQ, USU 4.0 and Multi Y If NIH-Defined Phase III Clinical Trial is Yes on any component of the application and the Overall if NIH-Defined Phase III Clinical Trial is No, provide Error The NIH-Defined Phase III Clinical Trial question on the Overall component must be marked as "Yes", in order for any NIH-Defined Phase III Clinical Trial question in any other component to be marked as "Yes". E PHS 398 Cover Page Human Subjects Phase III Clinical Trial (Y/N) N NIH, CDC, FDA, AHRQ, USU 4.0 and Multi Y For New and Renewal applications, if NIH Clinical Trial is Yes and Phase III Clinical Trial is not ‘Yes’ on all components of the application and NIH-Defined The NIH-Defined Phase III Clinical Trial question must be ‘No’ on the Overall component, if Phase III Clinical Trial question is ‘No’ for all other E Defined Defined Defined all all
eSub-validations-draft-08-21-2017.docx