The Alliance for Clinical Research Excellence and Safety (ACRES) released a global quality standard for clinical research sites – aimed at increasing data accuracy and integrity – earlier this year.
Larry Kennedy, PhD, ACRES chief quality officer (CQO) and VP of quality management systems, is leading the first evaluation effort underway in association with ActivMed Practices and Research, Inc.
Two commercial sites have completed the optional staff training on the standard, which will be available through all accrediting bodies and other sources once the accreditation process has officially launched, said Kennedy, who also is Chair of the Site Accreditation and Standards Initiative (SASI) and CEO Quality Management Institute.
The training “will dramatically accelerate the ability of a site’s leadership to validate their sites capacity,” he told us.
Kennedy explained, “This is more of a test of our standard than a test of the site as we have chosen two high-performing sites that will provide reasonable feedback on how to improve the initial step of self-assessment.”
ACRES also is developing the language of the accreditation protocols and the evidence requirements that will be used to apply the standard to a site’s performance, he said.
“Since the process of accreditation will be educational, collaborative and interactive, we hope to provide sites with the resources needed for all interested parties to achieve accreditation within a reasonable period of time after becoming a candidate,” Kennedy added.
The alliance is on schedule to begin the second phase of pressure testing the protocols with two new site organizations in early 2019 and begin accreditations by spring. Impact assessments are on track to begin at the end of 2019.
Kennedy noted that these dates are targets not deadlines: “Our process is being driven by strict adherence to the production of processes that promise high-quality outcomes and that can be applied with certainty,” he said.
A working group is developing a technology-assisted process known as “Dynamic Accreditation" in parallel with the testing and impact assessment, according to the alliance.
The process is described by ACRES as an innovative approach that will provide real-time feedback about site-performance to sites, sponsors, contract research organization (CROs), and others.