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Clinical Trial Pre-award Industry Workflow (Step 4: Establish CTRU…
Clinical Trial Pre-award Industry Workflow
Step 1: CRO must qualify
a. CRO submits site qualification form to PI
b. Site visit by sponsor (Visit includes potential collaborative institutions and third-party facilities)
Step 2: Confidentiality Agreement
a. PI receives and reviews CDA and protocol synopsis from CRO (Note: Contracts are with University, not the PI, PI does not sign the CDA)
b. Sponsored programs sends signed CDA to sponsor (cc: PI, designee and CTRU admin.
Step 3: Feasibility Assessment
CRO submits regulatory package (Includes draft CTA, budget, protocol, consent forms, regulatory documents)
Brainstorm implementation strategies
Identify roles of collaborative institutions and third-party facilities
Step 4: Establish CTRU Feasibility Committee and study personnel training and credentials
PI obtains letter of support from collaborative institutions and third-party facilities wuth services to be rendered and respective fees
Internal budget developed
PI submits proposal to CTRU Feasibility Committee
Applicable required training completed, documentation submitted
CTRU admin. develops and initiates grants eRA, budget and forms
Sponsored Programs reviews CTA and other documents, and confirms with collaborative partners
After review of final version, Sponsored Programs signs and sends CTA to CRO for execution
Step 5: Grants eRA upload and routing
Review and signature of PI, dean, finance, sponsored programs
Step 6: IRB
PI and CTRU completes FAU IRB application
Research Integrity submits signed IRB approval
PI and CTRU completes Central IRB application
Once Central IRB is approved, it is submitted to sponsored programs
Step 7: Award and Tag
Sponsored programs sends post award documents to research accounting, who establishes an award and tag number in workday
Step 8: Site Initiation Visit (SIV)
PI and CTRU schedule SIV with CRO
CRO sends regulatory and patient binders
Step 9: Site activation
After SIV and all documents are received, CRO send PI study site activation letter, and study supplies to team