Process Steps - Seattle Children's



|Reliable Method for Clinical Trial Agreement Processing |

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|Revision Date: 2012-08-09 |

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|Roles/Work Units Who Must Adopt This Process: |

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|Study Teams, Center Business Offices (CBO), Contract Negotiators, Clinical Research Budget Analysts (CRBA) |

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|STEP |STEP OWNER |TASK DESCRIPTION |TOOLS/SUPPLIES REQUIRED |

|1. |Study Team |Receives study protocol from Industry sponsor |Study protocol, sponsor’s draft consent if available |

| | | | |

|2. |Study Team |Requests contract and budget from sponsor |Contract and budget |

|3. | |Downloads Contract Initiation Request Form (CIRF) and|CIRF; process instructions |

| |Study Team |other required documents | |

|4. |Study Team |Collects PI signature, completes study team portion |CIRF |

| | |of CIRF | |

|5. |Study Team |Routes “package” to CBO |“Package”: (i) Sponsor Protocol; (ii) CIRF; (iii) sponsor’s |

| | | |draft consent, if available; (iv) contract; and (v) budget |

|6. |Study Team |Begins IRB application process |IRB application |

|7. |CBO |Receives “package” from Study Team |“Package” |

|8. |CBO |Obtains Center Director Approval |CIRF |

| | |Obtains Chief Academic Officer signature | |

|9. |CBO |Creates Advance Activity after obtaining Center |CIRF; ASU form |

| | |Director approval | |

|10. |CBO |Forwards “package” to CRBA@; |“Package” |

|11. |CBO |Provide Study Team with advance activity number from |Advance activity number |

| | |ORF; ORF service standard for activity setup is 5 | |

| | |business days | |

|12. |CRBA |Retrieves package from crba inbox; makes initial |“Package” |

| | |contact with Study Team | |

|13. |CRBA |Prepares draft cost budget for Study Team review |“Package” |

|14. |CRBA |Negotiates cost budget with Study Team |“Package;” draft cost budget document |

|15. |CRBA |Finalizes cost budget; obtains PI approval |Email approval from PI, |

| | | |Final cost budget document |

|16. |CRBA |Emails cost budget and Package to |“Package”; Final cost budget |

| | |ResAdmin@ | |

|17. |Negotiator |Initiates budget negotiation with sponsor |“Package”; Final cost budget |

|18. |Negotiator |Finalizes budget negotiation with sponsor |“Package”; Final cost budget |

|19. |Negotiator |Initiates contract negotiation |“Package”; Final budget |

|20. |Negotiator |Finalizes contract negotiation |“Package”; Final budget |

|21. |Negotiator |Notifies Study Team that terms have been reached |PDF of final cost budget and contract sent via email to PI |

|22. |Study Team |Signs final documents |Returns signed document(s) to Negotiator |

|23. |Negotiator |Obtains final CIRF signatures: |CIRF; Final contract and final contract budget |

| | |CRBA; CBM: Negotiator, Institutional signature | |

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