CRA Oversight - A Risk-based Approach
Using a “risk-based” approach has paid big dividends in clinical trials, as its principles are applicable to many different functional areas. This is no more visible than when applied to the oversight of Clinical Research Associates (CRA). Understanding how to use this approach when managing CRAs can help improve the quality, efficacy and efficiency of your trials.
This course presents tools for CRA selection, assignment and oversight that are based on quality risk management principles. This approach can support cost containment for non-project specific activities such as monitor oversight. You will learn to apply risk management models to GCP monitoring management and proactively plan quality monitoring evaluations based on risks from the protocol, the monitor and the site. Furthermore, you will learn to use resources wisely for monitoring oversight activities and budget for these activities.
Come to this live, interactive 90-minute session and you will be able to:
- Recognize the benefit of quality risk management models and tools applied to monitoring assignment and evaluation
- Apply quality risk management concepts when planning monitoring oversight
- Identify how to prioritize monitoring evaluation visits
This course will be of benefit to anyone responsible for clinical research monitoring management or quality assurance, including risk management in clinical sponsor research.
Sandra “SAM” Sather is a veteran industry consultant, who’s current focus is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience: Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. Clinical Pathways’ services include development and updates to clinical monitoring operations, compliance and auditing services, GCP subject matter expert, training management and development, mentoring, performance improvement systems analysis, staff management and more. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC); She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).