Performing Risk Assessment Within GCP
Quality risk management must be a focus of any clinical quality system for GCP sponsor stakeholders. Performing risk assessment involves a team approach involving various functional areas. Activities include risk assessment meeting facilitation, template and tool development, SOP and related document updates, risk identification at systems and project levels, and much more. Process and approaches to performing risk assessment in a GCP setting is covered in detail in this session, which is a “must have” to support the transition to clinical quality systems, including clinical quality risk management.
Come to this interactive live session and you will be able to:
- Identify the steps in clinical system and project level risk assessment
- Apply the steps of risk assessment and documentation to the stages of clinical research
- Recognize how to adapt a risk assessment tool to GCP practices and project activities
- Practice developing a risk assessment tool
This course will be of benefit to anyone responsible for clinical research site operations and GCP compliance (e.g., site directors, managers, monitors, compliance). Also, those who must comply with GCPs related to investigator oversight and audit readiness will find this course particularly useful.
Sandra “SAM” Sather’s 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).