Study Start-Up Agreement Policy

Policy Statement

Prior to the negotiation of a Cooperative Research and Development Agreement (CRADA) and following execution of a Confidential Disclosure Agreement (CDA), Lowcountry Center for Veterans Research (LCVR) will require industry sponsors to execute a Study Start-Up Agreement (SSUA) to provide for the provision and payment of regulatory submission services in connection with a sponsor’s study. Sponsor’s payment will cover the Institutional Review Board’s fee and the study coordinator’s time to prepare and submit regulatory documentation.

Background

LCVR has a board-approved Extramural Schedule of Fees (“Schedule”) that applies to all industry-sponsored studies. Included in that schedule are IRB fees and study start-up fees to cover regulatory submission of protocols. LCVR will apply the Schedule to the SSUA.

Guidelines

Following execution of a CDA and site selection, LCVR will provide the sponsor with a copy of the SSUA. If the sponsor modifies the SSUA, LCVR will forward the modifications to VA Office of General Counsel Specialty Team Advising Research (STAR) for review and approval.

Per the terms of the SSUA, should Ralph H. Johnson VA Medical Center, LCVR, and the Sponsor fail to enter into a CRADA, the Sponsor, in consideration for the provision of the services outlined in the SSUA, will pay LCVR non-refundable regulatory submission fees in accordance with the Schedule within thirty (30) days of receipt of invoice.

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