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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.

Clinical Research Acceleration and Facilitation Team (CRAFT)

The Clinical Research Acceleration and Facilitation Team (CRAFT) was established to provide researchers with improved feasibility assessment of all clinical trials and scientific review of investigator initiated trials. The primary focus of CRAFT is to support investigators in anticipating and identifying scientific, trial quality, and recruitment challenges prior to opening clinical studies for all PI initiated, non-federal, non-cancer-related clinical trial studies:

  • CRAFT will perform a feasibility assessment prior to study initiation, with re-review on an annual basis. 
  • CRAFT will conduct a scientific review for all investigator-initiated trial studies, required prior to IRB submission. Studies already reviewed for scientific merit (e.g., industry-sponsored, federal grant-sponsored multi-center) will not require scientific review by CRAFT, except consortium studies where scientific review is required as a condition of consortium participation.
  • CRAFT will help PIs monitor their study progress and offer appropriate guidance and support when and if specific challenges arise.

Please follow the following steps for CRAFT review:

  1. Send an email to CCRCRAFT@hs.uci.edu.
  2. CRAFT Application will be provided to PI and regulatory person (identified by the PI) by a CCR Regulatory Team member who will support in filling out the necessary information.
  3. Completed application will be reviewed by CRAFT at a monthly meeting.
  4. CRAFT will provide recommendations as to changes before submitting to IRB or approval to submit to IRB.

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.