004.18.3 N N Incl : Incl: Multi Y For Revision and Resubmission Answering to Activities Outside the W Research Activities outside ‘Yes’ NIH, V1.3 applications, If Activities Outside US on the Overall component and on and of US? ‘No’ CDC, the US is No on all components all other components is typically not Related FDA, of the application and the Overall allowed unless your Revision application Other AHRQ, if Activities Outside the US is (or Resubmission of a Revision) does not Project VA Yes, provide Warning include the components that the Activities Outside the US. Research Identify 004.19.1 N N Incl : Incl: Both Both A list of countries is required if Enter the countries with which international E NIH, V1.3 Activities outside of US is Yes cooperative activities are involved. and Countries CDC, Related FDA, Other AHRQ, Project VA Research Optional 004.19 and explanation Related Other Project Research Project 004.20.1 N N Incl : Incl: Both Both Attachment is required The Project Summary/Abstract attachment E NIH, V1.3 is required. and CDC, Related FDA, Other AHRQ, Project VA
Research and Related Other Project Activities outside of US? 004.18.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y For Revision and Resubmission applications, If Activities Outside the US is No on all components of the application and the Overall if Activities Outside the US is Yes, provide Warning Answering ‘Yes’ to Activities Outside the US 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 the Activities Outside the US. W Research and Related Other Project Identify Countries 004.19.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both A list of countries is required if Activities outside of US is Yes Enter the countries with which international cooperative activities are involved. E Research and Related Other Project Optional explanation 004.19 Research and Related Other Project Project 004.20.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both Attachment is required The Project Summary/Abstract attachment is required. E
eSub-validations-draft-9-14-2016.docx