Resubmission of a Revision) Yes, provide Warning does not include the components that involve Clinical Trial. PHS 398 Cover Human 008.2.1 N N Incl : V 2.0 Both Both An answer is required if The Human Subjects E Page Subjects NIH, the answer to Phase III Clinical Trial ‘Human Supplement Defined CDC, Subjects Clinical is question must be answered if Trial’ Phase III FDA, "Yes". the answer to the Human Clinical Trial AHRQ, Subjects Clinical Trial question (Y/N) VA is "Yes". PHS 398 Cover Human 008.2.2 N N Incl : V 2.0 Both Both If Human Subjects The Human Subjects E Page Subjects NIH, Clinical Trial is No, this Phase III Clinical Trial Supplement CDC, cannot be equal to Yes. question must be if the “No” Phase III FDA, answer to the Human Subjects Clinical Trial AHRQ, Clinical Trial question is “No” (Y/N) VA PHS 398 Cover Human 008.2.3 N All Multi Overall Y If NIH-Defined Phase III The NIH-Defined Phase III E Page Subjects Agencies Clinical Trial is Yes on Clinical Trial question on the Supplement any component of the Overall component must be Phase III application and the marked as "Yes", in order for Clinical Trial Overall if NIH-Defined any NIH-Defined Phase III (Y/N) Phase III Clinical Trial is Clinical Trial question in any No, provide Error other component to be marked as "Yes". PHS 398 Cover Human N All Multi Overall Y E 008.2.4 The NIH-Defined Phase III For New and Renewal Page Subjects Agencies applications, if Clinical Trial question must be Supplement Phase III on the Overall component, ‘No’ Phase III Clinical Trial is No on all if NIH-Defined Phase III Clinical Trial components of the Clinical Trial question is ‘No’ (Y/N) application and for all other components in the Phase III application. Clinical Trial is Yes on the Overall, then provide Error PHS 398 Cover Human 008.2.5 N All Multi Overall Y Answering to For Revision and Defined ‘Yes’ Page Subjects Agencies Resubmission on the Phase III clinical trial Supplement applications, If NIH Overall component and on ‘No’ Phase III Defined Phase III all other components is Clinical Trial clinical trial is No on
Yes, provide Warning Resubmission of a Revision) does not include the components that involve Clinical Trial. PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.1 N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Both An answer is required if the answer to ‘Human Subjects Clinical Trial’ is "Yes". The Human Subjects Phase III Clinical Trial question must be answered if the answer to the Human Subjects Clinical Trial question is "Yes". E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.2 N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Both If Human Subjects Clinical Trial is No, this cannot be equal to Yes. The Human Subjects Phase III Clinical Trial question must be “No” if the answer to the Human Subjects Clinical Trial question is “No” E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.3 N All Agencies Multi Overall Y If NIH-Defined Phase III Clinical Trial is Yes on any component of the application and the Overall if NIH-Defined Phase III Clinical Trial is No, provide Error The NIH-Defined Phase III Clinical Trial question on the Overall component must be marked as "Yes", in order for any NIH-Defined Phase III Clinical Trial question in any other component to be marked as "Yes". E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial (Y/N) 008.2.4 N All Agencies Multi Overall Y For New and Renewal applications, if Phase III Clinical Trial is No on all components of the application and Phase III Clinical Trial is Yes on the Overall, then provide Error The NIH-Defined Phase III Clinical Trial question must be ‘No’ on the Overall component, if NIH-Defined Phase III Clinical Trial question is ‘No’ for all other components in the application. E PHS 398 Cover Page Supplement Human Subjects Phase III Clinical Trial 008.2.5 N All Agencies Multi Overall Y For Revision and Resubmission applications, If NIH Defined Phase III clinical trial is No on Answering ‘Yes’ to Defined Phase III clinical trial on the Overall component and ‘No’ on all other components is Defined
SVS-Validations-Single-and-Multi-Project-April-2015-tracked-PreRelease.docx