Activities N N Incl : NIH, Incl: Multi Overall Y Provide error if If 'This Project involve E CDC, V1.3 'Activities Outside of US' activities outside of US' and outside of FDA, on Component is Yes is "Yes" on any US? AHRQ, and 'Activities Outside component of the VA, USU of US' on Overall is No. application, then "Yes" Other must be selected for the Project Overall component. Activities N N NIH, Incl: Multi Overall Y For New and Renewal If 'This Project involve E CDC, V1.3 applications, If Activities activities outside of US' and outside of FDA, Outside of US is No on is "No" on all US? AHRQ, all components of the components of the VA, USU application and the application, then "No" Other Overall Activities must be selected for the Project Outside of US is Yes, Overall component. provide Error N N Incl : NIH, Incl: Multi Overall Y For Revision and Answering to W Activities ‘Yes’ CDC, V1.3 Resubmission Activities Outside the and outside of FDA, applications, If Activities US on the Overall US? AHRQ, Outside the US is No on component and on ‘No’ VA, USU all components of the all other components is Other application and the typically not allowed Project Overall if Activities unless your Revision Outside the US is Yes, application (or provide Warning Resubmission of a Revision) does not include the components that the Activities Outside the US. Identify N N Incl : NIH, Incl: Both Both A list of countries is Enter the countries with E CDC, V1.3 required if Activities which international and Countries outside of US is Yes
and Other Project Activities outside of US? N N Incl : NIH, CDC, FDA, AHRQ, VA, USU Incl: V1.3 Multi Overall Y Provide error if 'Activities Outside of US' on Component is Yes and 'Activities Outside of US' on Overall is No. If 'This Project involve activities outside of US' is "Yes" on any component of the application, then "Yes" must be selected for the Overall component. E and Other Project Activities outside of US? N N NIH, CDC, FDA, AHRQ, VA, USU Incl: V1.3 Multi Overall Y For New and Renewal applications, If Activities Outside of US is No on all components of the application and the Overall Activities Outside of US is Yes, provide Error If 'This Project involve activities outside of US' is "No" on all components of the application, then "No" must be selected for the Overall component. E and Other Project Activities outside of US? N N Incl : NIH, CDC, FDA, AHRQ, VA, USU Incl: V1.3 Multi Overall 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 and Identify Countries N N Incl : NIH, CDC, Incl: V1.3 Both Both A list of countries is required if Activities outside of US is Yes Enter the countries with which international E
eSub-validations-draft-10-10-2017.docx