Activity Specific Lists to to Activity Single Com- Cross Agency Code ponent Component Specific (Inclusion Multi Type (Lists Form FOA & Project (Multi (Multi or Project (Y/N) (Y/N) Both Only) Only) Research Human Subjects 004.1.1 N N Incl : Incl: Both Both If Human Subjects Used Question When Human Subjects is Exemption E “No”, NIH, V1.3 is false, Exemption Number must Number must not be specified. and Involved? CDC, not be specified. Related FDA, Other AHRQ, Project VA Research Human Subjects 004.1.2 N N Incl : Incl: Both If Human Subjects Used Question When Human Subjects is W “No”, Assurance NIH, V1.3 and Involved? is false, provide a warning if Number may not be specified. CDC, Related Assurance Number is specified. FDA, Other AHRQ, Project VA Research Human Subjects 004.1.3 N N Incl : Incl: Both Both Must be true if Human Subjects The Subjects question E ‘Human Involved’ NIH, V1.3 and Involved? Clinical Trial question is true on must be "Yes" if the Human Subjects CDC, Related Cover Page Supp. Clinical Trial question on the PHS 398 FDA, Other Cover Page Supplement is “Yes”. AHRQ, Project VA Research Human Subjects 004.1.4 N N Incl : Incl: Both Provide Warning if Human The Human Subject Assurance Number W NIH, V1.3 Subject Involved is Yes and Is the may be requested later as part of the eRA and Involved? CDC, Project Exempt from Federal Commons Just In Time (JIT) process. Related FDA, Regulations is No and Is the IRB Other AHRQ, review Pending is Yes and Project VA Human Assurance Number is not provided. Research Human Subjects 004.1.5 N N Incl : Incl: Multi Y If Human Subject Involved is Yes If Human Subjects Involved is "Yes" on any E NIH, V1.3 on any component of the component of the application, then "Yes" and Involved? CDC, application and the Overall must be selected for the Overall Related FDA, Human Subject Involved is No, component Other AHRQ, provide Error Project VA
Component (Y/N) (Y/N) Agency Specific (Lists Form FOA Activity Specific Lists Activity Code (Inclusion & to Single Multi Project or Both to Com- ponent Type (Multi Only) Cross (Multi Project Only) Research and Related Other Project Human Subjects Involved? 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 Involved? 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 Involved? 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 Involved? 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 Involved? 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
eSub-validations-draft-2-5-2016.docx