PHS 398 Human N Incl 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 components in the and NIH-Defined application. Phase III Clinical Trial is Yes on the Overall, then provide Error PHS 398 Human N Multi Y For Revision and Answering to W ‘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
PHS 398 Cover Page Human Subjects Phase III Clinical Trial (Y/N) N Incl 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 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 Phase III Clinical Trial question is ‘No’ for all other components in the application. 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 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 Defined W all all all
eSub-validations-draft-07-12-2018.docx