Activity to Specific Applies Com- Lists to Cross Agency Activity Single Type Specific Code (Multi (Lists Form (Inclusion Multi (Multi Shared FOA & Project Project (Y/N) (Y/N) Specific Exclusion) or Both Only) Only) Research Human 004.1.1 N N Incl : Incl: Both Both If Human Subjects Used When Human Subjects is E NIH, V1.3 Question is false, Exemption Exemption Number “No”, and Subjects CDC, Number must not be must not be specified. Related FDA, specified. Other AHRQ, Project VA 004.1.2 N N Incl : Incl: Both W Research Human If Human Subjects Used When Human Subjects is NIH, V1.3 and Subjects Question is false, provide a Number may “No”, Assurance CDC, Related warning if Assurance Number not be specified. FDA, Other is specified. AHRQ, Project VA Research Human 004.1.3 N N Incl : Incl: Both Both Must be true if Human The Subjects E ‘Human NIH, V1.3 and Subjects Subjects Clinical Trial question must be Involved’ CDC, Related Involved question is true on Cover "Yes" if the Human Subjects FDA, Other Page Supp. Clinical Trial question on the AHRQ, Project PHS 398 Cover Page VA Supplement is “Yes”. Research Human 004.1.4 N N Incl : Incl: Both Provide Warning if Human The Human Subject W NIH, V1.3 Subject is Yes and Is Assurance Number may be and Subjects CDC, the Project Exempt from requested later as part of the Related Involved FDA, Federal Regulations is No eRA Commons Just In Time Other AHRQ, and Is the IRB review (JIT) process. Project VA Pending is Yes and Human Assurance Number is not provided. 004.1.5 N N Incl : Incl: Multi Y If Human Subject is If Human Subjects Involved is E Research Human NIH, V1.3 Yes on any component of the "Yes" on any component of and Subjects CDC, application and the Overall the application, then "Yes" Related Involved FDA, Human Subject is must be selected for the Other AHRQ, No, provide Error Overall component Project VA
(Y/N) Shared (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & Exclusion) Applies to Single Multi Project or Both to Com- Type (Multi Only) Cross (Multi Project Only) Research and Related Other Project Human Subjects 004.1.1 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both If Human Subjects Used Question is false, Exemption Number must not be specified. When Human Subjects is “No”, Exemption Number must not be specified. E Research and Related Other Project Human Subjects 004.1.2 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both If Human Subjects Used Question is false, provide a warning if Assurance Number is specified. When Human Subjects is “No”, Assurance Number may not be specified. W Research and Related Other Project Human Subjects 004.1.3 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Both Must be true if Human Subjects Clinical Trial question is true on Cover Page Supp. The ‘Human Subjects Involved’ question must be "Yes" if the Human Subjects Clinical Trial question on the PHS 398 Cover Page Supplement is “Yes”. E Research and Related Other Project Human Subjects 004.1.4 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Both Provide Warning if Human Subject Involved is Yes and Is the Project Exempt from Federal Regulations is No and Is the IRB review Pending is Yes and Human Assurance Number is not provided. The Human Subject Assurance Number may be requested later as part of the eRA Commons Just In Time (JIT) process. W Research and Related Other Project Human Subjects 004.1.5 N N Incl : NIH, CDC, FDA, AHRQ, VA Incl: V1.3 Multi Y If Human Subject Involved is Yes on any component of the application and the Overall Human Subject Involved is No, provide Error If Human Subjects Involved is "Yes" on any component of the application, then "Yes" must be selected for the Overall component E
SVS-Validations-Single-and-Multi-Project-April-2015-tracked-PreRelease.docx