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 You must answer the E Update to “Clinical Page Subjects NIH, the answer to question if you answer existing rule ‘Human Trial?” Supplement Clinical Trial CDC, Subjects is Yes to the Human (modified Involved’ “Are (Y/N) FDA, "Yes" on the Other Subjects question language on Involved?” AHRQ Project Information on the Other Project error message), page. Information Form. Forms D, March 2016 Release PHS 398 Cover Human 008.1.2 N N Incl : V 2.0 Both Both If Human Subjects You must answer Yes to the E Update to Page Subjects NIH, Defined Phase III questions if existing rule “Clinical Trial?” Supplement Clinical Trial CDC, Clinical Trial is true, you answer Yes to the (modified (Y/N) FDA, Human Subjects Clinical Phase III language on “Agency-Defined AHRQ Trial must be true Clinical error message), Trial” question. Forms D, March 2016 Release PHS 398 Cover Human 008.1.3 N N Incl : V 2.0 Multi Overall Y If Human Subjects The Human Subjects Clinical E Page Subjects NIH, Clinical Trial is Yes on Trial question on the Overall Supplement Clinical Trial CDC, any component of the Component must be marked (Y/N) FDA, application and the as "Yes", in order for any AHRQ Overall if Human Human Subjects Clinical Trial Subjects Clinical Trial is question in any component to No, provide Error be marked as "Yes". PHS 398 Cover Human 008.1.4 N N Incl : V 2.0 Multi Overall Y For New and Renewal The Human Subjects Clinical E Page Subjects NIH, applications, if Human Trial question must be on ‘No’ Supplement Clinical Trial CDC, Subjects Clinical Trial is the Overall component, if the (Y/N) FDA, No on all components of Human Subjects Clinical Trial AHRQ the application and question is for all other ‘No’ Human Subjects Clinical components in the application. Trial is Yes on the Overall, then provide Error.
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. You must answer the “Clinical Trial?” question if you answer Yes to the “Are Human Subjects Involved?” question on the Other Project Information Form. E Update to existing rule (modified language on error message), Forms D, March 2016 Release 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 You must answer Yes to the “Clinical Trial?” questions if you answer Yes to the “Agency-Defined Phase III 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 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 provide Error. 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-draft-2-5-2016.docx