Human AHRQ, Project Information is ‘Yes’. Subjects VA PHS Research N N Incl : V 2.0 Both Both Required if Human Subjects is The Inclusion of Women and E Plan NIH, yes and Exemption is not E4 Minorities attachment is Plan Attachments: CDC, on Other Project Information required if the response to the Inclusion of FDA, form within the same Human Subjects question on Women and AHRQ, component the Other Project Information is Minorities VA and the Exemption ‘Yes’ Number is not 4. PHS Research N N Incl : V 2.0 Both Both Required if Human Subjects is The Inclusion of Children E Plan NIH, yes and Exemption is not E4 attachment is required if the Plan Attachments: CDC, on Other Project Information response to the Human Inclusion of FDA, form within the same Subjects question on the Other Children AHRQ, component Project Information is and ‘Yes’ VA the Exemption Number is not 4. PHS Research N N Incl : V 2.0 Excl: Both Both Required if Vertebrate The Vertebrate Animals E Plan NIH, S10 Animals Used Question is Yes attachment is required if the Plan Attachments: CDC, on Other Project Information response to the Vertebrate FDA, form within the same Vertebrate/Animals Subject Animals AHRQ, component Used question on the Other VA Project Information is ‘Yes’ PHS Research 010.11 N N V 2.0 Plan Plan Attachments: Select Agent Research PHS Research N N Incl : V 2.0 Both Overall Required if multiple DP/ PIs The Multiple PI Leadership Plan E Plan NIH, are included with the attachment on the PHS 398 Plan Attachments: CDC, submission Research Plan must be Multiple PI FDA, included if multiple PD/PIs have Leadership AHRQ, been included on the Plan VA Senior/Key Person Profile. PHS Research N N Incl : V 2.0 Both Overall Return error if Leadership For multiple PD/PI applications, E Plan NIH, Plan is included and there is be sure to mark each PD/PI Plan Attachments: CDC, only one PD/PI identified with with a project role of PD/PI on Multiple PI FDA, the submission the Senior/Key Person Profile. If Leadership AHRQ, not intending to submit a Plan VA multiple PD/PI application, remove the Multiple PI Leadership Plan attachment.
Human Subjects AHRQ, VA Project Information is ‘Yes’. PHS Plan Research Plan Attachments: Inclusion of Women and Minorities N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Both Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Women and Minorities attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Research Plan Attachments: Inclusion of Children N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Both Required if Human Subjects is yes and Exemption is not E4 on Other Project Information form within the same component The Inclusion of Children attachment is required if the response to the Human Subjects question on the Other Project Information is ‘Yes’ and the Exemption Number is not 4. E PHS Plan Research Plan Attachments: Vertebrate Animals N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Excl: S10 Both Both Required if Vertebrate Animals Used Question is Yes on Other Project Information form within the same component The Vertebrate Animals attachment is required if the response to the Vertebrate/Animals Subject Used question on the Other Project Information is ‘Yes’ E PHS Plan Research Plan Attachments: Select Agent Research 010.11 N N V 2.0 PHS Plan Research Plan Attachments: Multiple PI Leadership Plan N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Overall Required if multiple DP/ PIs are included with the submission The Multiple PI Leadership Plan attachment on the PHS 398 Research Plan must be included if multiple PD/PIs have been included on the Senior/Key Person Profile. E PHS Plan Research Plan Attachments: Multiple PI Leadership Plan N N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Overall Return error if Leadership Plan is included and there is only one PD/PI identified with the submission For multiple PD/PI applications, be sure to mark each PD/PI with a project role of PD/PI on the Senior/Key Person Profile. If not intending to submit a multiple PD/PI application, remove the Multiple PI Leadership Plan attachment. E
SVS-Validations-Single-and-Multi-Project-April-2015-tracked-PreRelease.docx