Other Project Rule Categories Activity Specific Error/ Form Field Rule# Validation Error Message Comments Lists to to Warning Activity Single Com- Cross Agency Code Specific Multi Type (Lists Form FOA & (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 When Human Subjects is Exemption E “No”, NIH, V1.3 Question is false, Exemption Number must not be specified. and Involved? CDC, Number must not be specified. Related FDA, Other AHRQ, Project VA Research Human Subjects 004.1.2 N N Incl : Incl: Both If Human Subjects Used When Human Subjects is W “No”, Assurance NIH, V1.3 and Involved? Question is false, provide a Number may not be specified. CDC, Related warning if Assurance Number is FDA, Other specified. 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 may be requested later as part of the eRA and Involved? CDC, the 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 E NIH, V1.3 on any component of the any component of the application, then and Involved? CDC, application and the Overall "Yes" must be selected for the Overall Related component
Other Project Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency Specific (Lists Form FOA Activity Specific Lists Activity Code & to Single Multi or Both to Com- 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 Human Subjects Involved? 004.1.5 N N Incl : NIH, CDC, Incl: V1.3 Multi Y If Human Subject Involved is Yes on any component of the application and the Overall 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-9-14-2016.docx