the Overall, then provide Error. PHS 398 Cover Human 008.1.5 N N Incl : V 2.0 Multi Overall Y For Revision and Answering to Clinical W ‘Yes’ Page Subjects NIH, Resubmission Trial on the Overall Supplement Clinical Trial CDC, applications, If Clinical component and to Clinical ‘No’ (Y/N) FDA, Trial is No on all Trial on all other components AHRQ components of the is typically not allowed unless application and the your Revision application (or Overall Clinical Trial is Resubmission of a Revision) Yes, provide Warning does not include the components that involve Clinical Trial. PHS 398 Cover Human N N Incl : V 2.0 Incl: SIngle Provide a warning if Clinical Trials are not typically W Update to 008.1.6 Page Subjects NIH, S10 Human Subjects allowed for this type of funding existing rule Supplement Clinical Trial CDC, Clinical Trial is mark opportunity announcement. (modified (Y/N) FDA, language on ‘Yes’. AHRQ error message), Forms D, March 2016 Release PHS 398 Cover Human 008.2.1 N N Incl : V 2.0 Both Both An answer is required if You must answer the E Update to Page Subjects NIH, the answer to Phase III existing rule ‘Human “Agency-Defined Supplement Defined CDC, Subjects Clinical is Clinical question if you (modified Trial’ Trial” Phase III FDA, "Yes". answer Yes to the language on “Clinical Clinical Trial AHRQ question. error Trial?” (Y/N) message), Forms D, March 2016 Release PHS 398 Cover Human 008.2.2 N N Incl : V 2.0 Both Both If Human Subjects You cannot answer Yes to the E Update to Page Subjects NIH, Clinical Trial is No, this Phase III existing rule “Agency-Defined Supplement Defined CDC, cannot be equal to Yes. Clinical if you (modified Trial”question Phase III FDA, anser No to the language on “Clinical Clinical Trial AHRQ question error Trial?” (Y/N) message), Forms D,
the Overall, then provide Error. PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.5 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For Revision and Resubmission applications, If Clinical Trial is No on all components of the application and the Overall Clinical Trial is Yes, provide Warning Answering ‘Yes’ to Clinical Trial on the Overall component and ‘No’ to Clinical Trial on all other components is typically not allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve Clinical Trial. W PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.6 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Incl: S10 SIngle Provide a warning if Human Subjects Clinical Trial is mark ‘Yes’. Clinical Trials are not typically 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 Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.1 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 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 Update to existing rule (modified language on error message), Forms D, March 2016 Release PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.2 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If Human Subjects Clinical Trial is No, this cannot be equal to Yes. You cannot answer Yes to the “Agency-Defined Phase III Clinical Trial”question if you anser No to the “Clinical Trial?” question E Update to existing rule (modified language on error message), Forms D, Defined Defined
eSub-validations-draft-9-14-2016.docx