This professionally developed, interactive course is ideal for anyone working within clinical trials who wants to gain a deep understanding of audits and regulatory inspections. Created by seasoned clinical research professionals, this course delivers comprehensive insights into what sponsors, contract research organisations (CROs), and clinical investigators can expect during an audit or inspection, and how to prepare effectively.
Participants will explore the full audit and inspection process, including the purpose of audits, common findings, limitations, the audit/inspection cycle, data collection, analysis, interpretation, and final reporting. The course also covers essential documentation, audit checklists, and the importance of maintaining inspection readiness at all times.
In the highly regulated world of clinical research, audits are routine and critical to compliance. This course emphasises the importance of being audit-ready every day, not just when an audit is announced. It is designed to build both competence and confidence in your role within the clinical trial process.
Who Should Enrol:
This course is suitable for professionals in roles such as:
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Clinical Research Associates (CRAs)
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Clinical Trial Managers and Study Coordinators
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Quality Assurance Personnel
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Regulatory Affairs Specialists
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Investigators and Clinical Site Staff
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Clinical Trial Assistants (CTAs)
Whether you’re currently involved in audits or inspections, or simply want to strengthen your preparedness, this training offers valuable, practical knowledge relevant across clinical research functions.
Download Course Summary Leaflet
Click the link above to explore the complete course content in our PDF leaflet.
