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