CRO Oversight: Risk Assessment & Action Planning
Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors. Every process – from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation – requires a high degree of risk-based diligence to satisfy regulators.
The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses, monitors and documents risk management activities is critical to both compliance and success. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring audit readiness.
Come to this interactive live session and you will be able to:
- Identify the risk-based study management approaches to CRO oversight
- Recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management
- Build a risk-based assessment tool for CRO management
- Identify key approaches to planning and preparing to outsource
This course will be of benefit to anyone responsible for clinical research CRO/Vendor selection and Management. Also, those that must comply with the GCPs related to CRO oversight and audit readiness will find this training particularly useful.
Sandra “SAM” Sather current focus of consulting 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).