Phase III Clinical components in the Trial is Yes on application. the Overall, then provide Error PHS 398 Human N Multi Y For Revision and W Answering to ‘Yes’ Cover Subjects NIH, 4.0 all Resubmission Phase III Page CDC, and applications, If clinical trial on the FDA, NIH Clinical Trial Overall component Phase III AHRQ, is Yes and NIH and on all other ‘No’ Clinical USU Phase III components is Trial clinical trial is not typically not allowed (Y/N) on all ‘Yes’ components of unless your Revision the application application (or and the Overall Resubmission of a NIH Revision) does not Phase III clinical include the trial is Yes, components that provide Warning involve Phase III clinical trial. PHS 398 Cover Page PHS 398 Program N N V Incl: Provide warning if Program Income is W Update to Cover Income 25.1 NIH, 2.0 T01, checked yes for typically not allowed existing Page CDC, T02, Training grants for this type of funding rule FDA, T03, applications opportunity (removed AHRQ, T14, announcement. KM1) USU T42, T90, T90/R90, Forms D, March T32, 2016 T34, Release
Phase III Clinical Trial is Yes on the Overall, then provide Error components in the application. PHS 398 Cover Page Human Subjects Phase III Clinical Trial (Y/N) N NIH, CDC, FDA, AHRQ, USU 4.0 and Multi Y For Revision and Resubmission applications, If NIH Clinical Trial is Yes and NIH 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 PHS 398 Cover Page Program Income N N NIH, CDC, FDA, AHRQ, USU V 2.0 Incl: T01, T02, T03, T14, T42, T90, T90/R90, T32, T34, 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 (removed KM1) Forms D, March 2016 Release all 25.1
eSub-validations-draft-10-10-2017.docx