Course Description

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

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Learning Objectives

• Review similarities and differences in risk-based auditing and monitoring
• Examine the structure of the quality assurance/quality control relationship
• Apply risk assessment and management principles to clinical quality assurance
• Review elements of risk-based auditing and compare to traditional auditing practices
• Discuss how the timing of the audit impacts risk assessment and control
• Evaluate recent noncompliance trends and regulatory focus for sites, sponsors/CROs/monitors, and IRBs

Who Should Attend

• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers
• Sponsor Investigators

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.