March 2016 Release PHS 398 Cover Human 008.2.3 N Incl : Multi Overall Y If NIH-Defined Phase III The NIH-Defined Phase III E Page Subjects NIH, Clinical Trial is Yes on Clinical Trial question on the Supplement CDC, any component of the Overall component must be Phase III FDA, application and the marked as "Yes", in order for Clinical Trial AHRQ Overall if NIH-Defined any NIH-Defined Phase III (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 ‘No’ Phase III FDA, NIH-Defined Phase III component, if NIH-Defined Clinical Trial AHRQ Clinical Trial is not ‘Yes’ Phase III Clinical Trial (Y/N) on all components of question is for all other ‘No’ the application and components in the 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 ‘No’ Phase III FDA, Clinical Trial is Yes and on 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 Resubmission of a Revision) the 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 not allowed for this type of existing rule Supplement CDC, T03, T14, Training grants funding opportunity (modified FDA, T42, T90, applications announcement. language on AHRQ T90/R90, error
March 2016 Release PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.3 N Incl : NIH, CDC, FDA, AHRQ Multi Overall 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 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, 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
eSub-validations-draft-9-14-2016.docx