BADER CRADA

What was unique about the BADER CRADA was its complexity in how many parties were brought in and how quickly that allowed such a diverse group of organizations to work together.

The BADER Consortium was a multi-institutional endeavor that worked in concert and partnership with medical treatment facilities to conduct innovative, high-impact, clinically relevant research that further strengthened evidence-based orthopaedic rehabilitation care.

This was made possible through an omnibus Cooperative Research and Development Agreement, or CRADA, an innovative strategy that created standard operating procedure addressing intellectual property, publications, data sharing, subject inventions and licensing among all partners.

To accelerate the establishment of clinical research projects and research thrust partnerships, BADER Consortium leadership worked with the Medical Research Law Office of the Staff Judge Advocate, United States Army Medical Research and Material Command (USAMRMC) to develop the CRADA.

To establish a Consortium CRADA, examples of CRADAs from the Navy, Army, and the NIH were gathered. The content of each example CRADA was reviewed and categorized. Like categories were then combined and systematically reduced to establish generalized guidelines in each CRADA activity category. Each category was then tested against applicable federal regulations and active policies. The resulting “master” Consortium CRADA was virtually exercised using an array of Consortium-related scenarios. The resulting policy and implementation procedures such as on-boarding projects and the declaration and approval of amendments were developed. Prior to full implementation, the BADER master CRADA was trialed at two Government sites. It was used to rapidly onboard, six (6) partner institutions within four (4) months of completing its development and testing.

This model CRADA was a unique mechanism designed to cover all activities associated with a dynamic, nationwide clinical research consortium. It replaced the former practice of negotiating CRADA for each research-related activity.

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