The Alliance for Clinical Research Excellence and Safety (ACRES) just launched what it calls a road-tested program to accredit clinical research sites worldwide.
The accreditation process is grounded in a quality-based global standard for clinical research sites. It realizes the six-year effort of the ACRES Site Accreditation and Standards Initiative (SASI), carried out by experts in clinical trials from every part of the clinical research endeavor to encourage, recognize, and reward excellence at sites.
Applauding the ongoing commitment of the Association of Clinical Research Professionals (ACRP) to promoting certification and advancing professionalism in the clinical work force, ACRES Vice President for Quality Management Systems Dr. Larry Kennedy says the ACRES program “reciprocates beautifully” with ACRP’s efforts because it fills in a “gap in the continuum of certifications” by adding a way for individuals to assess sites.
ACRP’s Bridget Gonzales, CCRC, was a “key player” in the vetting of the ACRES program, Kennedy added. “She’s a big part of its success,” he said. Gonzales is Director of Training and Professional Development at ACRP.
“We’re excited to showcase this important contribution to raising the bar of professionalism in the clinical trial industry,” said ACRP Executive Director Jim Kremidas. “We are ready to roll up our sleeves and work with everyone to promote better clinical trials with robust certifications and meaningful quality standards,” he said.
The SASI Team published the first global Quality Standard in The New England Journal of Medicine one year-ago for public review and comment. Since then, the standard has been revised and pressure-tested at a variety of active research sites, both in the private sector and academia, while concurrently developing accreditation protocols.
To house and manage the accreditation process, ACRES has created a specialized internal operating division known as the Site Accreditation and Standards Institute. The institute will operate within the overall ACRES nonprofit framework, but with separate leadership and multi-stakeholder oversight to ensure the integrity and independence of the process. Within the institute, individual operational units will manage the further development and implementation of the accreditation process itself and the continuing evaluation, updating, and expanding of the Quality Standard for sites.
Author: Michael Causey