With changes to ICH E6 R2, including the need for risk-based analysis, planning, and mitigation at the research site level, the Association of Clinical Research Professionals (ACRP) recently announced the adoption of the Clinical Research Quality Manager (CRQM) credential under a new partnership with the Quality Management Institute (QMI). CRQM-credentialed professionals become eligible to become ACRES Site Accreditation and Standards Institute (SASI) Clinical Research Site Surveyors and hence play a key role in the ACRES-SASI Site Accreditation currently targeting clinical research sites. The ACRP and QMI partnership seeks to drive individual and collective excellence, contributing to more productive, effective, and safe clinical research sites over the long run.
Guidance Updated due to Changing Conditions: Cost, Complexity & Scale of Clinical Trials
Why is this all relevant? Well, with technological and clinical research changes over the past couple decades, ICH GCP global compliance standards, were updated by the International Conference of Harmonization (ICH). They introduced E6 R2 for improvements to the unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Why did ICH make the changes?
First and foremost, the scale, complexity, and cost of clinical trials have significantly increased, generating heretofore unforeseeable challenges and opportunities. Evolution in technology and risk-management processes offer new opportunities to increase efficiency and focus on relevant activities for drug sponsors (and their contractors) and clinical investigational sites. Back when the first ICH standards were introduced, much of the clinical trials process was paper-based. How things have changed! Now—with ubiquitous electronic data recording and reporting, coupled with a heretofore unforeseeable clinical trials scale, complexity, and volume—comes the need for updates to the ICH standards to deal with present-day realities. And for example, centralized monitoring is now possible as is more efficient approaches to clinical trial design, conduct, and oversight.
ICH E6 R2 introduces new standards of conduct, oversight, recording, and reporting while sponsors and sites can continue to ensure human subject protection and reliability of trial results. Hence, risk-based planning and quality—driven by systems-based quality management principles—become the topic of regulatory inspections and sponsor audits of clinical investigational sites. ACRP’s commitment to clinical research professionals’ continuous improvement necessitated a commitment to get involved and offer a new credential to its members.
Why is this Important News?
The ACRES Site Accreditation and Standards Institute site accreditation represents a breakthrough in the introduction of a systems-based, comprehensive and holistic clinical investigational site-level accreditation for improving the productivity, quality and safety of these organizations worldwide. It is the first clinical investigational site-focused accreditation of its kind—developed over the past years by a highly committed, competent, and experienced group of volunteers from not only the Alliance for Clinical Research Excellence & Safety but also Quality Management Institute and individual contributors from prominent academic research centers, government, non-profits and industry. The standards have been informed and influenced by the changes in clinical research that have occurred over the past decade and can help research sites organize and prepare to not only meet the changes brought by ICH E6 R2 but also contribute to a healthy, productive and quality-driven research site culture.
What is ACRES-QC S001?
ACRES-SASI’s “Standard for Clinical Research Site Quality Management” offers ACRES-QC S001—focused QM fundamentals and training, that when effectively applied to clinical research, creates a culture of competence and conscience that produces reliable outcomes. By adopting the standard research, sites can better 1) define the values and skills of high-performing site working culture; 2) focus on the participant in the trial and the patient in the treatment; 3) reduce waste and inefficiencies in the clinical trials process; 4) contribute to the shortening of drug development timelines; and 5) improve overall public confidence in the drug development process.
Larry Kennedy, Executive Director of ACRES-SASI and CEO of the Quality Management Institute, guided the writing of the ACRES Standard and the development of the new ACRES-SASI Accreditation. He noted that Greg Koski, Chair Emeritus of ACRES-SASI, has said, “We must get beyond a culture of compliance and strive for a culture of conscience, one in which we do the right thing not because we are required to do so but because it is the right thing to do.”
Why is the CRQM Important for ACRP and other members to consider?
The CRQM credential will enable individuals to increase not only their competency and capabilities but also increase their professional status as quality managers in their own domain. As conveyed by Jim Kremidas, ACRP Executive Director and a professional with many years of experience in the clinical trials process, “We are excited to expand our industry-leading programs with the CRQM credential,” adding that the “program allows us to provide our members with a specialized quality management credential backed by a trusted mark of excellence in clinical research.”
The CQRM credential is a comprehensive solution that will verify and validate the human values, collaborative skills, and process knowledge of clinical research professionals. It is designed to provide learners with the knowledge base to integrate human competencies with science and technologies in an intelligent system of quality management.
Call to Action: Interested in learning more? Visit the ACRP online at their website.