Activity to Specific Lists Applies Activity to Com- Cross Agency Code ponent Specific (Inclusion Multi Type (Lists Form & (Multi (Multi Mandatory FOA or Project Project (Y/N) (Y/N) Specific Both Only) Only) Planned Study Title X of 017.1.1 N N Incl : V 1.0 Excl: Both Provide Warning if Human Subjects are involved W NIH, T15, T32, Y but no Planned Enrollment Planned Enrollment CDC, T34, T35, Report(s) for inclusion has been Report form is not part FDA, T36, K12, Report included. of the application AHRQ T37, D71, when HS = Y and D43, Exemption not E4 U2R, T01, T02, T03, T14, T42, T90, T90/R90, TU2, S10, C06, UC6, G20, X02, X01, I01, IP1, IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Planned Study Title X of 017.1.2 N N Incl : V 1.0 Both Provide warning if Planned Enrollment Report(s) W NIH, Y Planned Enrollment was submitted with no data. If CDC, Report is submitted with not a Delayed Onset study, is FDA, Report all zeros planned enrollment data AHRQ needed? 017.2 Planned Study Title: Report
Mandatory (Y/N) (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) Planned Report Study Title X of Y 017.1.1 N N Incl : NIH, CDC, FDA, AHRQ V 1.0 Excl: T15, T32, T34, T35, T36, K12, T37, D71, D43, U2R, T01, T02, T03, T14, T42, T90, T90/R90, TU2, S10, C06, UC6, G20, X02, X01, I01, IP1, IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 Both Provide Warning if Planned Enrollment Report form is not part of the application when HS = Y and Exemption not E4 Human Subjects are involved but no Planned Enrollment Report(s) for inclusion has been included. W Planned Report Study Title X of Y 017.1.2 N N Incl : NIH, CDC, FDA, AHRQ V 1.0 Both Provide warning if Planned Enrollment Report is submitted with all zeros Planned Enrollment Report(s) was submitted with no data. If not a Delayed Onset study, is planned enrollment data needed? W Planned Report Study Title: 017.2
eSub-validations-Oct2015%20.docx