The project was a collaboration between BioNJ, Rutgers University, and the law firm of Sheppard Mullin Richter & Hampton LLP, and has been reviewed and endorsed by Rutgers and Rowan University.
“The purpose of the form is to reduce the negotiation time for translation studies being conducted at New Jersey institutions,” said BioNJ president and chief executive officer Debbie Hart. “Our objective is to free up much needed resources and time for research, accelerating the development of state-of-the-art therapeutics and diagnostics emerging from research discoveries.”
Although some studies may require modification to the form for specific trial needs, the template aims to provide a reliable starting point for sponsors collaborating with NJ research institutions. Guidance documents will be developed over the next few months to help users better understand key issues addressed in the form. Future plans of the working group will include forms for Letters of Indemnification, Guidance on Subject Injury and Sponsor Insurance Coverages.