A Cooperative Research and Development Agreement (CRADA) is used for any study that is industry sponsored or industry funded. The VA Technology Transfer Program (TTP) is the agency responsible for overseeing VA-specific CRADAs and the model agreement templates that are used for various types of studies.
Industry sponsored studies are those in which the company owns the protocol and include:
- Clinical Trial Phase I/II
- Clinical Trial Phase III/IV
- Investigational Device Clinical Trial
- Basic Science Studies
- Data Collection Studies and
- Material Transfer Agreement (MTA)
Industry funded studies are those in which the PI has created a protocol and has sought out industry support in the form of funds or materials and can include:
- PI Initiated Studies (Biomedical, Data Collection, or Clinical)
- Material Transfer Agreements (MTA)
SIBCR and VA Regional Counsel will negotiate these agreements on behalf of VA with the exception of MTAs which are negotiated by VA R&D.
Some industry sponsors have Master templates with TTP in which all terms have been agreed upon and are acceptable VA-wide. More information about TTP and CRADAs can be found here:
Please see CRADA under the Research Activity Cycle of this website.
USE OF VA SERVICES
Any use of VA Clinical Services (pathology, pharmacy, imaging, etc.) solely for research must be included in the study budget and paid for by the industry partner. The following forms are used to inform the services when a requested procedure is study related to ensure that VA bills SIBCR appropriately for those services: Research Use Agreement, Research Procedure Request.
If you are interested in participating in a clinical trial, the Clinical Research Unit (CRU) is available to you for both planning, study start-up and study performance. With its expertise in nursing and research administration, the CRU is able to provide a variety of services including specialized diagnostic tests and procedures in support of clinical research programs. Information about services and pricing for industry and non-industry sponsored studies can be found on the intake forms.
SIBCR negotiates CRADA agreements concurrently with the study proceeding through the appropriate IRB or IACUC and R&D approval processes, with the goal of executing the agreement when IRB approval is imminent.
When negotiating budgets, it is important to include the cost of all VA services used that are outside the parameters of “standard of care." For instance, if the study calls for an MRI or a blood test that would not normally be done as part of the patient’s usual care, it will need to be included in the study budget and the sponsor will be required to pay for that service. The policy for reimbursing the VA for clinical services is found here.
All CRADAs administered by SIBCR must include an indirect cost rate consistent with our federal rate or a Board approved rate.
Clinical trials must be registered with ClinicalTrials.gov by the party that owns the protocol. Please visit the site for guidance and requirements for registration and read more at SIBCR's clinicaltrials.gov page.
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