On December 26, 2007, then Under Secretary for Health Michael Kussman, MD, signed the VHA Directive 2007-044 Mandating Use of Cooperative Research and Development Agreements (CRADAs), described at 15 USC §3710a. Effective March 2008, CRADAs must be used to establish terms and conditions for industry sponsored research studies. CRADAs are a highly flexible form of federal contract. They offer sponsors protections for their pre-existing inventions and a means to establish in advance ownership and treatment of any inventions that may result from the collaboration.
Each CRADA is a three-way contract signed by the industry sponsor, VACHS and VACREF. Because CRADAs must be signed by VA, each CRADA must undergo review and approval by VA.
To ease the process of negotiating CRADAs with industry sponsors, the VA created a variety of model CRADAs for specific research relationships. The following are the types of model CRADAs available:
Basic Science CRADA Model – For collaborative research, development, engineering, testing or evaluation studies when a VA investigator designs or contributes substantively to the design of the statement of work, and the study does not involve human subjects or materials derived from humans.
Data Collection CRADA Model – For projects that meet all of the following criteria: a) the SOW calls for the retrospective or prospective collection of data from patient medical records, such as Registries, data mining and outcomes analysis; b) the SOW does not call for any interaction with patients; c) no intellectual property is anticipated from the project and neither party is interested in pre-commitment of intellectual property rights; and d) the sponsor is not seeking individually identifiable information as defined in the CRADA.
Device Clinical Trial CRADA Model – For collaborative research, development, engineering, testing or evaluation studies involving devices.
Phase I-IV Clinical Trial CRADA Model – For phase I-IV Clinical Trials where the sponsor writes the protocol and holds the investigational new drug (IND)
Principal Investigator-Initiated CRADA Model – When a VAMC participates in a study of an FDA approved drug or device already on the market, for which a VA investigator designs the protocol and holds any investigational new drug (IND) application. A commercial company may provide funds, materials and/or equipment. The study may involve human subjects or materials derived from humans.