Clinical Studies
In This Section:
- Clinical Research Unit (CRU)
- Reimbursing VA for Clinical Costs
- Request for CRU Services DOC
- Research Use Agreement DOC
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For clinical studies sponsored by pharmaceutical companies, the investigator should advise SIBCR as soon as the determination to participate is made. Sponsor contact information including name, email, and phone number will be needed. SIBCR will negotiate the Cooperative Research and Development Agreements (CRADA).
SIBCR will also assist with budget review and finalization including any requirement for human subject review costs. Please note that you will need to negotiate with the sponsor for the study budget, but SIBCR will assist you where possible.
Please be sure that you apply the indirect cost rate to the TOTAL direct costs of your industry-sponsored trial. All direct costs, including those that are often listed in subcategories (e.g. pharmacy set-up, study start-up fees, advertising etc.) must be included in this calculation.
SIBCR will try to negotiate an acceptable payment schedule if you specifically ask us to do so. As part of the payment schedule, we will also try to negotiate a non-refundable start-up fee.
The investigator and study staff should complete the Research Use Agreement(s) DOC prior to finalizing the study budget in order to assure that all costs for conducting the study will be covered. The VAPSHCS must be reimbursed for all services utilized in support of a research project that are over and above those required for standard care. See the Research Reimbursement Policy for more information.
If the Clinical Research Unit can assist in the study or perform required procedures, those services should also be included in the budget.
The investigator should ensure that all regulatory and compliance issues are addressed, including possible requirements for an FDA Investigational New Drug application.
Please see Policy Manual for more information.