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) PHS Study Title X of 033.1.1 N N Incl: Excl: Both Provide Warning if PHS Human Subjects are W New Rule for NIH, T15, T32, Forms D, March Y Inclusion Enrollment involved but no PHS AHRQ T34, T35, 2016 Release Report form is not part Inclusion Enrollment T36, K12, of the application when Report(s) for inclusion T37, D71, HS = Y and Exemption has been included. D43, Report not E4 U2R, T01, T02, T03, T14, Note: Training T42, T90, component of a T90/R90, complex should be TU2, excluded from this rule. S10, C06, UC6, G20, X02, OT1, X01, I01, IP1, IU1, IS1, I21, I34, I50, IK1, IK2, IK3, IK4, IK5, IK6 PHS Study Title X of 033.1.2 N N Incl: Both Generate a warning if Different studies with the W New Rule for NIH, Forms D, March Y the study title provided same title cannot be AHRQ 2016 Release is not unique. submitted for the same grant Report PHS Delayed Onset 033.2.2 N N Incl: Both If Delayed Onset is Yes If you answered to E New Rule for “Yes” NIH, then no values should the Delayed Onset Study Forms D, March Study? AHRQ exist on the form except then the only value that 2016 Release for the Study Title should exist on the form is the Study Title. Report PHS Delayed Onset 033.2.3 N N Incl: Both If Delayed onset study If you answered No to the E New Rule for NIH, is No then all Ethnic Delayed onset study Forms D, March Study? AHRQ and Racial Category question then you must 2016 Release cell data values are provide a value for each
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) PHS Report Study Title X of Y 033.1.1 N N Incl: NIH, AHRQ 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 PHS Inclusion 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 PHS Inclusion Enrollment Report(s) for inclusion has been included. W New Rule for Forms D, March 2016 Release PHS Report Study Title X of Y 033.1.2 N N Incl: NIH, AHRQ Both Generate a warning if the study title provided is not unique. Different studies with the same title cannot be submitted for the same grant W New Rule for Forms D, March 2016 Release PHS Report Delayed Onset Study? 033.2.2 N N Incl: NIH, AHRQ Both If Delayed Onset is Yes then no values should exist on the form except for the Study Title If you answered “Yes” to the Delayed Onset Study then the only value that should exist on the form is the Study Title. E New Rule for Forms D, March 2016 Release PHS Delayed Onset Study? 033.2.3 N N Incl: NIH, AHRQ Both If Delayed onset study is No then all Ethnic and Racial Category cell data values are If you answered No to the Delayed onset study question then you must provide a value for each E New Rule for Forms D, March 2016 Release