Other Project Information Rule Categories to / Form Field Rule# Validation Error Message Lists Applies to Cross Code Multi Overall, Other (Lists Form FOA & (Multi or or Project (Y/N) Both Both Only) Human N N Incl: Both Both If Human Subjects Used When Human Subjects E NIH, V1.3 Question is false, is Exemption and Subjects “No”, CDC, Exemption Number must Number must not be Involved? FDA, not be specified. specified. AHRQ Other Project VA, USU Human N N Incl: Both Overall If Human Subjects Used When Human Subjects W NIH, V1.3 and Subjects Question is false, is “No”, Assurance CDC, Involved? provide a warning if Number may not be FDA, Assurance Number is specified. AHRQ Other specified. Project VA, USU Human 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 Involved’ CDC, Involved? question is true on Cover be "Yes" if the Human FDA, Page Supp. Subjects Clinical Trial AHRQ Other question on the PHS Project 398 Cover Page VA, Supplement is USU “Yes”. Human N N Incl Incl: Both Overall Provide Warning if The Human Subject W NIH, V1.3 Human Subject Involved Assurance Number may and Subjects CDC, is Yes and Is the Project be requested later as Involved? FDA, Exempt from Federal part of the eRA AHRQ Regulations is No and Is Commons Just In Time Other the IRB review Pending (JIT) process. Project VA, is Yes and Human USU
Other Project Information Form Field Rule# Rule Categories Validation Error Message (Y/N) (Lists Form FOA Lists Code & to Multi or Both Applies to Overall, Other or Both Cross (Multi Project Only) and Other Project Human Subjects Involved? N N NIH, CDC, FDA, VA, USU 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 and Other Project Human Subjects Involved? N N NIH, CDC, FDA, VA, USU Incl: V1.3 Both Overall 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 and Other Project Human Subjects Involved? N N Incl : NIH, CDC, FDA, VA, USU 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 and Other Project Human Subjects Involved? N N Incl NIH, CDC, FDA, VA, USU Incl: V1.3 Both Overall 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 The Human Subject Assurance Number may be requested later as part of the eRA Commons Just In Time (JIT) process. W / AHRQ AHRQ AHRQ AHRQ
eSub-validations-draft-07-12-2018.docx