Planned Enrollment Report Rule Categories Activity to Specific Applies Error/ Form Field Rule# Validation Error Message Comments Lists to Warning Agency Activity Com- Cross Code ponent (Inclusion Multi Type (Lists Form & (Multi (Multi 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 FDA, T36, K12, Report inclusion has been part of the application AHRQ T37, included. when HS = Y and Update to existing D71, (Added Exemption not E4 D43, U2R, OT1) Note: Training T01, T02, component of a T03, T14, complex should be T42, T90, excluded from this T90/R90, rule. TU2, S10, C06, UC6, G20, X02, OT1, X01, I01, IP1, IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6
Planned Enrollment Report Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments (Y/N) (Y/N) Agency (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)
eSub-validations-draft-9-14-2016.docx