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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.

  • Initial Communication
    • Sponsor or Principal Investigator (PI) express interest in conducting a clinical research at UCI

  • 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

  • Protocol Acceptance
    • Sponsor sends feasibility questionnaire to PI
    • Sponsor sends protocol to PI
    • PI/department decide whether to accept the clinical research study

  • 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

  • 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

  • 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.

  • 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.

  • 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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