WIRB-Copernicus Group Supports Accelerated Clinical Trial Agreement

April 20, 2015
Applied Clinical Trials Editorial Staff

Applied Clinical Trials

The ACTA was initiated in 2012 by the National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards program in collaboration with representatives from several pharmaceutical companies to facilitate negotiations between institutional research sites and industry sponsors.

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for human research and software solutions, announced that it will encourage members of its Global Research Network (GRN) to accept the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multi-center clinical trials.

The ACTA was initiated in 2012 by the National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards program in collaboration with representatives from several pharmaceutical companies to facilitate negotiations between institutional research sites and industry sponsors. The goal was to create a straightforward and unambiguous document which clearly sets forth the regulatory and contractual obligations of both parties, and presents language which – while perhaps not ideal for either party – is acceptable to both. Adoption and use of the ACTA would expedite the contract process and reduce the time it takes to start up clinical trials.  

While the Accelerated Clinical Trial Agreement (ACTA) was initiated in 2012, it took two years to develop, and is just being introduced now. To date, approximately 225 institutions have agreed to the terms of the ACTA. WCG aims to increase that number significantly by promoting ACTA to the 1,200 institutions that belong to its GRN, which is a group comprised of research-intensive hospitals and universities, including one-third of all U.S. academic medical centers, 27 of which are CTSA institutions and have agreed to accept the ACTA without revision.

 

Read the full release.