(Y/N) Phase III Clinical Trial is Clinical Trial question in any No, provide Error other component to be marked as "Yes". PHS 398 Cover Human 008.2.4 N Incl : Multi Overall Y For New and Renewal The NIH-Defined Phase III E Page Subjects NIH, applications, if NIH Clinical Trial question must be Supplement CDC, Clinical Trial is Yes and on the Overall component, ‘No’ Phase III FDA, NIH-Defined Phase III if NIH-Defined Phase III Clinical Trial AHRQ Clinical Trial is not ‘Yes’ Clinical Trial question is ‘No’ (Y/N) on all components of the for all other components in the application and application. Phase III Clinical Trial is Yes on the Overall, then provide Error PHS 398 Cover Human 008.2.5 N Incl : Multi Overall Y For Revision and Answering to W ‘Yes’ Page Subjects NIH, Resubmission Phase III clinical trial on the Supplement CDC, applications, If NIH Overall component and on ‘No’ Phase III FDA, Clinical Trial is Yes and all other components is Clinical Trial AHRQ NIH Defined Phase III typically not allowed unless (Y/N) clinical trial is not ‘Yes’ your Revision application (or on all components of the Resubmission of a Revision) application and the Overall NIH does not include the Phase III clinical trial is components that involve Yes, provide Warning Phase III clinical trial. PHS 398 Cover Disclosure 008.24 Page Permission Supplement Statement PHS 398 Cover Program N N Incl : V 2.0 Incl: Single Provide warning if Program Income is typically W Update to Page Income NIH, T01, T02, checked yes for Training not allowed for this type of existing rule Supplement CDC, T03, T14, grants applications funding opportunity (modified FDA, T42, T90, announcement. language on AHRQ T90/R90, error message), TU2,T15, Forms D, T32, T34, March 2016 T35, T36, Release T37, K12, D43, D71, U2R PHS 398 Cover Program N N Incl : V 2.0 Incl : Single Provide error id Program Program Income is typically E Update to
(Y/N) Phase III Clinical Trial is No, provide Error Clinical Trial question in any other component to be marked as "Yes". PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.4 N Incl : NIH, CDC, FDA, AHRQ Multi Overall Y For New and Renewal applications, if NIH Clinical Trial is Yes and NIH-Defined Phase III Clinical Trial is not ‘Yes’ on all components of the application and Phase III Clinical Trial is Yes on the Overall, then provide Error The NIH-Defined Phase III Clinical Trial question must be ‘No’ on the Overall component, if NIH-Defined Phase III Clinical Trial question is ‘No’ for all other components in the application. E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.5 N Incl : NIH, CDC, FDA, AHRQ Multi Overall Y For Revision and Resubmission applications, If NIH Clinical Trial is Yes and NIH Defined Phase III clinical trial is not ‘Yes’ on all components of the application and the Overall NIH Phase III clinical trial is Yes, provide Warning Answering ‘Yes’ to Phase III clinical trial on the Overall component and ‘No’ on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve Phase III clinical trial. W PHS 398 Cover Page Supplement Disclosure Permission Statement 008.24 PHS 398 Cover Page Supplement Program Income N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Single Provide warning if checked yes for Training grants applications Program Income is typically not allowed for this type of funding opportunity announcement. W Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Program N N Incl : V 2.0 Incl : Single Provide error id Program Program Income is typically E Update to