Cover Page Supplement Rule Categories Error/ Form Field Rule# Validation Error Message Applies Applies Activity to to Com- Cross Specific Single ponent Agency Lists Activity Project, Type Specific Form FOA Code Multi (Multi (Multi Shared (Lists (Inclusion & Project Project Project (Y/N) (Y/N) Agencies) Exclusion) or Both Only) Only) PHS 398 Cover PD/PI Page Information Supplement (prefix, first, middle, last, suffix) PHS 398 Cover Human 008.1.1 N N Incl : V 2.0 Both Both An answer is required if The Human Subjects Clinical Trial question must be answered if E Page Subjects NIH, the answer to the answer to Subjects on the Other Project ‘Human ‘Human Involved’ Supplement Clinical Trial CDC, Subjects is "Yes" Information page is "Yes". Involved’ (Y/N) FDA, on the Other Project AHRQ Information page. PHS 398 Cover Human N N Incl : V 2.0 Both Both If Human Subjects The Human Subjects Clinical Trial question must be if the E 008.1.2 “Yes” Page Subjects NIH, Defined Phase III Clinical answer to Human Subjects NIH-Defined Phase III Clinical Trial Supplement Clinical Trial CDC, Trial is true, Human is “Yes. (Y/N) FDA, Subjects Clinical Trial must AHRQ be true PHS 398 Cover Human 008.1.3 N N Incl : V 2.0 Multi Overall Y If Human Subjects Clinical The Human Subjects Clinical Trial question on the Overall E Page Subjects NIH, Trial is Yes on any Component must be marked as "Yes", in order for any Human Supplement Clinical Trial CDC, component of the Subjects Clinical Trial question in any component to be marked (Y/N) FDA, application and the Overall as "Yes". AHRQ if Human Subjects Clinical Trial is No, provide Error PHS 398 Cover Human 008.1.4 N N Incl : V 2.0 Multi Overall Y For New and Renewal The Human Subjects Clinical Trial question must be on the E ‘No’ Page Subjects NIH, applications, if Human Overall component, if the Human Subjects Clinical Trial Supplement Clinical Trial CDC, Subjects Clinical Trial is question is for all other components in the application. ‘No’ (Y/N) FDA, No on all components of AHRQ the application and Human Subjects Clinical Trial is Yes on the Overall, then
Cover Page Supplement Form Field Rule# Rule Categories Validation Error Message Error/ (Y/N) Shared (Y/N) Agency Specific (Lists Agencies) Form FOA Activity Specific Lists Activity Code (Inclusion & Exclusion) Applies to Single Project, Multi Project or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) PHS 398 Cover Page Supplement PD/PI Information (prefix, first, middle, last, suffix) PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.1 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both An answer is required if the answer to ‘Human Subjects Involved’ is "Yes" on the Other Project Information page. The Human Subjects Clinical Trial question must be answered if the answer to ‘Human Subjects Involved’ on the Other Project Information page is "Yes". E PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.2 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If Human Subjects Phase III Clinical Trial is true, Human Subjects Clinical Trial must be true The Human Subjects Clinical Trial question must be “Yes” if the answer to Human Subjects NIH-Defined Phase III Clinical Trial is “Yes. E PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.3 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y If Human Subjects Clinical Trial is Yes on any component of the application and the Overall if Human Subjects Clinical Trial is No, provide Error The Human Subjects Clinical Trial question on the Overall Component must be marked as "Yes", in order for any Human Subjects Clinical Trial question in any component to be marked as "Yes". E PHS 398 Cover Page Supplement Human Subjects Clinical Trial (Y/N) 008.1.4 N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Multi Overall Y For New and Renewal applications, if Human Subjects Clinical Trial is No on all components of the application and Human Subjects Clinical Trial is Yes on the Overall, then The Human Subjects Clinical Trial question must be ‘No’ on the Overall component, if the Human Subjects Clinical Trial question is ‘No’ for all other components in the application. E Defined
eSub-validations-Oct2015%20.docx