Submit protocol to IRB (if you are using clinical data with personal identifiers)
Complete the R&A form, RCOI form, draft budget proposal, - submit to SPA along with draft ICF and protocol - click here
Negotiate budget with sponsor
Include SPA Clinical Trial Administrator on the cc during the negotiations which will provide status updates (SPA is also required to have a copy of the final budget).
Complete Coverage Analysis documentation
Route the final agreement for PI signature - submit to SPA
Include SPA Clinical Trial Administrator on the cc during the negotiations which will provide status updates (SPA is also required to have a copy of the final budget)
Complete Coverage Analysis documentation – the Coverage Analysis does not need to be approved before the SSUA is fully executed.
Route the final agreement for PI signature - submit to SPA
Negotiate legal terms of the agreement with sponsor on behalf of the PI and the university.
Build out the coverage analysis shell for the study team to enter in costs, effort, and coverage information. Coverage analysis approval is not needed in order to fully execute a SSUA.
Route the final agreement with PI signature for institutional signatory to sign.
Cannot submit for institutional signature until the below items are received:
Final Agreement with PI signature
Copy of Final start-up budget
Initiate process with post award to set up a financial account for the study
