This type of research funding requires a Cooperative Research and Development Agreement (CRADA) between the VA, NFFRE, and the sponsor.  VA CRADAs are overseen by the VA Technology Transfer Program (TTP).  CRADAs for the North Florida/South Georgia Veterans Health System (NF/SG VHS) are negotiated by NFFRE and the VA Regional Counsel.

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There are two categories of industry-funded studies, and the following are the usual types of studies in each category:

 

Sponsor-Initiated

• Basic science study

• Clinical trial phase I or II

• Clinical trial phase III or IV

• Investigational device clinical trial

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Principal Investigator (PI)-Initiated

• Clinical research

• Biomedical research

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Sponsor- or PI-Initiated

• Data collection

• Material transfer agreement (MTA)

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The TTP has model agreement templates for each type of study, and some industry sponsors have their own master templates with the VA TTP in which all terms have been agreed upon and are acceptable VA-wide.  More information about TTP and CRADAs, including templates and forms, can be found at this TTP web page.

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Conditions of Industry-Funded Research

 

Budget

• Clinical Service Performed for Research.  When the budget is negotiated, it must be established that the service is being done strictly for research and is not a part of standard care. Therefore, the cost for the service will be included in the sponsor’s budget.  For instance, if the study calls for an imaging study or a blood test that would normally not be done as part of care, that service must be included in the study sponsor’s budget, that is, the sponsor must pay for that service.

• Indirect Cost (IDC).  The budget for every CRADA administered by NFFRE must include an IDC at the current rate approved by the NFFRE Board; see NFFRE rates here.

 

Use of VA Clinical Services. As noted above, VA clinical services may be used for research purposes, and the use of these services must be included in the sponsor’s budget. 

 

Clinical Trials Center (CTC).  If you are interested in conducting a clinical trial, the CTC is available for all needs in conducting clinical research: planning, start-up, regulatory requirements, and study coordination. With expertise in nursing and research administration, the CTC provides a variety of clinical research services including specialized diagnostic tests and procedures. 

 

ClinicalTrials.Gov.  Clinical trials must be registered with ClinicalTrials.gov by the party that owns the protocol.  Please visit that website for guidance and requirements for registration. Also, read more at NFFRE’s ClinicalTrials.gov Registry web page.

 

If you are interested in starting negotiations on a CRADA or have other questions,

please contact VHANFLNFFREAdmin@va.gov.