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Starting a Trial
We help our investigators navigate the robust and yet at times complex system of clinical research here at UCI.
Our focused Start-Up and Regulatory Team members will provide support to PIs from the initial communication to site initiation and each step in between.
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Initial Communication
- Sponsor or Principal Investigator (PI) express interest in conducting a clinical research at UCI
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Confidential Disclosure Agreement
- Sponsor sends CDA to PI
- PI submits CDA to Sponsored Projects Administration (SPA ) for clinical trials or Applied Innovation (AI) for research except clinical trials
- CDA must be executed in order to receive and review protocol
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Protocol Acceptance
- Sponsor sends feasibility questionnaire to PI
- Sponsor sends protocol to PI
- PI/department decide whether to accept the clinical research study
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Site Qualification Visit
- Sponsor verifies site has facilities, staff, equipment and patient population necessary to complete the clinical research study
- Sponsor and PI concur to pursue Contract
Parallel Start-up Submissions
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IRB Submission
- Regulatory team/Study team member completes IRB submission to IRB for local UCI review or single IRB review (UC Reliance)
- Submission includes protocol, informed consent form (ICF)/ assent form, and other supporting regulatory documents (e.g. drug/device brochures, conflict of interest, etc.).
- IRB approval letter does not allow PI and study team to begin enrollment, all institutional approvals must be in place to open the study
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Coverage Analysis & Budget Negotiation
- Regulatory team/ Study team complete study request in RedCap, including upload of required documents (i.e. protocol, ICF, draft budget and contract, etc.) to CCR.
- CCR manages the submission by building the protocol calendar, completing the coverage analysis (CCR or PFS vendor), and exporting internal budget from within OnCore.
- Study team, CCR or PFS (vendor) ensure all research items & services are accounted for and negotiate the budget to reach final budget agreement.
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Contract Negotiation
- CCR Start-up team/Study team submits the study documents (i.e. protocol, draft budget & contract) to SPA or AI in Kuali Research (KR) and emails the KR proposal link to SPA/AI team.
- SPA/AI negotiates the contract to reach final mutual agreement of contract terms.
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Document Alignment
- CCR or PFS (vendor) completes document alignment once the IRB, coverage analysis, budget, and contract are final.
- Document alignment is an institutional requirement to ensure financial risk is mitigated by way of alignment across all documents.
- Once alignment is complete, CCR/Study team (ORU, non-CCR) submits KR signoff in order to execute the contract and allow the study to open.
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