Training Cover Page Clinical Trial question Supplemental Form on the Cover Page Plan Supplement is “Yes” N N Incl: Both E Update to existing PHS Vertebrate 014.8.1 Incl: Required Vertebrate A Vertebrate Animals T01, T02, T03, rule message 398 Animals NIH, Animals is true on attachment must be T14, T42, T90, CDC, Other Project included if the T90/R90, Update to existing FDA, Information form within response to the TU2,T15, T32, rule Training AHRQ the same component Vertebrate Animals T34, T35, T36, (removed KM1) Used Question on the T37, K12, D43, Plan Other Project D71, U2R Information form is ‘Yes’. PHS Select Agent 014.9 398 Research Training Plan PHS Multiple PD/PI N N Incl: Incl: Required if multiple The Multiple PD/PI E Update to existing T01, T02, T03, rule 398 Leadership NIH, PD/ PIs are included Leadership Plan T14, T42, T90, (removed KM1) Plan (if CDC, with the submission attachment must be T90/R90, applicable) FDA, included if multiple TU2,T15, T32, Training AHRQ Senior/Key entries with T34, T35, T36, the PD/PI role have T37, K12, D43, Plan been included on the D71, U2R Senior/Key Person Profile form. PHS Multiple PD/PI N N Incl: Incl: Return error if For multiple PD/PI E Update to existing T01, T02, T03, rule 398 Leadership NIH, Leadership Plan is applications, be sure to T14, T42, T90, (removed KM1) Plan (if CDC, included and there is mark each PD/PI with T90/R90, applicable) FDA, only one PD/PI a project role of PD/PI TU2,T15, T32, Training AHRQ identified with the on the Senior/Key T34, T35, T36,
Training Plan Cover Page Supplemental Form Clinical Trial question on the Cover Page Supplement is “Yes” PHS 398 Training Plan Vertebrate Animals 014.8.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Required Vertebrate Animals is true on Other Project Information form within the same component A Vertebrate Animals attachment must be included if the response to the Vertebrate Animals Used Question on the Other Project Information form is ‘Yes’. E Update to existing rule message Update to existing rule (removed KM1) PHS 398 Training Plan Select Agent Research 014.9 PHS 398 Training Plan Multiple PD/PI Leadership Plan (if applicable) N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Required if multiple PD/ PIs are included with the submission The Multiple PD/PI Leadership Plan attachment must be included if multiple Senior/Key entries with the PD/PI role have been included on the Senior/Key Person Profile form. E Update to existing rule (removed KM1) PHS 398 Training Multiple PD/PI Leadership Plan (if applicable) N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, Return error if Leadership Plan is included and there is only one PD/PI identified with the For multiple PD/PI applications, be sure to mark each PD/PI with a project role of PD/PI on the Senior/Key E Update to existing rule (removed KM1)
eSub-validations-draft-2-5-2016.docx