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General Contract Considerations

With rare exception, the VAMC functions as a separate site (i.e., not a sub-site). Generally, a Cooperative Research and Development Agreement (CRADA) is established and serves as the legal agreement between the VA and the sponsor of the study. Budgets are typically negotiated by the investigator, Larry Sama (VAMC), and Amy Morris (VAMC). Funding is sent directly to the VA.

What is a Cooperative Research and Development Agreement (CRADA)?

A CRADA is a legal agreement between a federal agency and one or more non-federal parties. The purpose is to foster federal/private collaborations to bring new technology to the marketplace.

The government owns the invention rights of inventions that government employees made during work hours, using government resources, or that bear a direct relation to the official duties of the inventor. The government may provide personnel, services, facilities, equipment, intellectual property, and other resources, but not funds. Non-federal party may provide funds, personnel, services, facilities, equipment, intellectual property, or other resources. 

If there is not already a Master CRADA in place between the VA and the study sponsor/company, the VA has a model CRADA that can be submitted to the company for review. Any requested revisions to an existing CRADA, or negotiations for a new CRADA will be handled by Larry Sama at the VAMC Foundation. The investigator should provide information for the company's contracts representative to Larry Sama.

Cooperative Groups

If Wake Forest is part of a cooperative group and the VA is used to recruit patients, the rules of the cooperative group dictate how to enroll patients at the VA site. Each cooperative group is different. The investigator should contact Robyn Gore in the Office of Sponsored Programs at WFBMC, the PI responsible for the cooperative group, and the cooperative group officials to determine the proper procedure under the terms of the cooperative group agreement in place with Wake Forest.

Large Pharmaceutical Industry Companies

The VA has pre-negotiated, master agreements in place with many large pharmaceutical companies. Companies may have existing Master Cooperative Research and Development Agreements (“CRADA”) and/or existing Master CDAs in place. Review the list of companies with CRADAs and CDAs in place with the VA

If there is no CRADA in place, the VA has a model CRADA that can be submitted to the company for review. Any requested revisions to an existing CRADA or negotiations for a new CRADA will be handled by Larry Sama at the VAMC Foundation. The investigator should provide contact information for the company's contract representative to Larry Sama. 

Small Pharmaceutical Industry Companies

If there is no Master CDA or CRADA in place, a new CRADA (either a Master CRADA or a "one-off" CRADA) can be put into place. Contact Robyn Gore or Larry Sama at the VA Foundation for more information.

Other Contract Types (Federally Funded, Investigator Initiated, etc.)

Contracts for these types of studies will vary by individual study. Please contact Robyn Gore, rgore@wakehealth.edu, if you have any questions.

Intergovernmental Personnel Act (IPA)

An Intergovernmental Personnel Act (IPA) contract allows the VAMC to reimburse Wake Forest (and vice versa) for salary and fringe associated with research conduct. Staff travel costs cannot be reimbursed thru an IPA. 

PI time cannot be reimbursed through an IPA. Funds associated with PI effort remain at the VAMC. Read about award setup for more information.