Applied Clinical Trials
The Independently Accredited Clinical Research Audit Academy is registering delegates for its first cohort commencing May 4. “Audit Academy” blends high-quality virtual training and development facilitated by Pharm-Olam, with robust, independent, and internationally recognized accreditation awarded by IAOCR to deliver Internationally Qualified Clinical Research Auditors (designatory letters AIACR).
Auditors hold a critical role in the pharmaceutical and clinical research industry. However, the quality of clinical research audits is variable because there is a gap in defining and accepting internationally recognized audit standards and, until now, there have been no standards for Qualifying individuals. This anomaly means that audit frequency generally isn’t taking a risk-based approach or focus. Often auditors visit the same organizations on multiple occasions to review the same areas. This is extremely costly to organizations and the industry as a whole, but the value of repetitive audits in terms of risk-reduction and quality assurance is questionable. Ensuring the individuals engaged to conduct clinical research audits are fit-for-purpose is an essential first step in raising industry standards.
“High-quality, risk-based auditing is essential for ensuring patient safety and data integrity to provide greater assurance of the competence of the required oversight. It’s critical that people working in this space are both competent and confident in their roles so that we can trust them to conduct high quality audits,” states Daniel W. Burgess, Chief Compliance Officer, Pharm-Olam. “Our focus with the Audit Academy is to provide confidence throughout the vendor network by ensuring that all audits are conducted to a consistently high standard.”
The program will involve a variety of live theory sessions, knowledge assessments and immersive evidence-based simulations. Upon completion successful candidates will become “Internationally Qualified Clinical Research Auditors” and awarded the designatory letters and professional status “AIACR”, establishing they have evidenced their skills, knowledge and professional behaviors within the multi-faceted field of clinical research auditing which can be leveraged across the entire clinical research industry as a quality standard.
Pharm-Olam is committed to supporting the clinical research industry as a whole by offering training to their entire vendor network and beyond-to any clinical research organization wanting to ensure that their clinical research auditors are competent and fit-for-purpose.
The Audit Academy provides a 12-week virtual program covering key topics from Audit Principles, Quality Management Systems, Audit Findings, Case Management and beyond. Dedicated to ensuring competence in clinical research auditing, the first cohort will start on May 4, 2020.
“Auditors play an integral role in reducing risk to patients, clinical research and organizational reputation,” explains Jacqueline Johnson North, Chief Executive, IAOCR. “IAOCR is committed to working in partnership with organizations that are passionate about quality and patient safety. We were delighted when Pharm-Olam asked us to work with them to provide independent accreditation for this program, which marks an important step forward for the industry.”
IAOCR, the International Accrediting Organization for Clinical Research, is dedicated to working in partnership with organizations to provide Internationally Qualified Professionals for the Clinical Research Industry-raising standards and reducing risk to patients, clinical research and organizational reputation. IAOCR operates globally, providing accreditation across a variety of clinical research roles and tasks, from early talent to executive leadership. IAOCR accreditations are internationally recognizable and mapped to the International Standard Classification of Education Framework developed by UNESCO.