Activity to Specific Applies Lists to Activity 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 W Update to existing NIH, T15, T32, rule Y involved but no Planned Planned Enrollment CDC, (removed KM1) T34, T35, Enrollment Report(s) for Report form is not part FDA, T36, K12, Report inclusion has been of the application AHRQ T37, D71, included. when HS = Y and Update to existing D43, (Added Exemption not E4 U2R, T01, T02, OT1) Note: Training T03, T14, component of a T42, T90, complex should be T90/R90, excluded from this TU2, rule. S10, C06, UC6, G20, X02, OT1, 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 W NIH, Y Planned Enrollment Report(s) was submitted CDC, Report is submitted with with no data. If not a FDA, Report all zeros Delayed Onset study, is AHRQ planned enrollment data needed?
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, OT1, 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 Note: Training component of a complex should be excluded from this rule. Human Subjects are involved but no Planned Enrollment Report(s) for inclusion has been included. W Update to existing rule (removed KM1) Update to existing (Added OT1) 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
eSub-validations-draft-2-5-2016.docx