Contracting Timelines

The Contracting/IRB process for VA trials:

1. Execution of the CDA between the sponsor, PI and VA.
2. Agreement that the VA will serve as a site for the specific corporate sponsored trial/research

Steps that usually occur in parallel

  • CRADA Negotiations

    • 3. The appropriate CRADA model is supplied
    to the sponsor. The sponsor’s legal team
    reviews the CRADA model and makes changes
    (with track changes ‘on’) and returns to the
    Executive Director (ED) of the Biomedical
    Research Foundation.

    4. The ED reviews the sponsor’s edits and
    passes the redlined CRADA on to the
    appropriate VA STAR attorney.



    • 5. The CRADA negotiations continue until
    there is a meeting of the minds.




    • 6. CRADA is executed by having all
    parties (sponsor, PI, ED and Medical
    Center Director) sign STAR attorney
    approved CRADA.

    Approximately 2 months turnaround
    time if sponsor is timely with CRADA edits.

  • Budget Negotiations

    • 3B. Study budget is submitted by sponsor
    to research coordinator.





    • 4B. The ED and the research coordinator
    discuss the budget and provide the sponsor
    with any necessary changes based on BRF
    CRADA contracting fee structure and projected
    costs for per patient visit specific procedures.

    5B. Budget negotiations continue until there is
    a meeting of the minds.




    • 6B. Final budget gets incorporated into
    approved CRADA.



    • Approximately 1-2 months of turnaround time.

  • IRB/R&D Approval

    • 3A. The research coordinator completes
    the IRB package that is pre-reviewed by
    one member of the IRB committee.
    Comments and suggestions are passed
    back to the coordinator.


    • 4A. The research coordinator submits a
    completed package to IRB for a full
    committee review (The VA IRB meets
    twice monthly).


    • 5A. If not approved on the first
    submission, the IRB provides
    contingencies that must be addressed
    with the package to be resubmitted
    for a second review.

    6A. Once the IRB has approved, the
    project is then submitted to the VA’s
    R&D committee for approval (which also
    meets twice per month).

    Approximately 2-2.5 months turnaround
    time for IRB with an additional 0.5-1
    month for R&D approval.