Preparing for a Clinical Research Inspection

The event titled 'Preparing for a Clinical Research Inspection' is an online course designed to equip clinical research teams with the essential skills and knowledge needed to be always inspection and audit ready. This interactive training program provides practical advice and strategies tailored for NHS clinical research teams, focusing on improving Quality Assurance (QA) and preparation for regulatory inspections and audits. Participants will explore and understand the processes involved in inspections and audits, including who conducts them and the reasons behind their selection.Led by Karl Ward, a Lead Nurse for Research and Innovation (Education) at Leeds Teaching Hospitals NHS Trust and an experienced NIHR GCP Facilitator, the course includes discussions on navigating potential problems in clinical research. Karl brings a wealth of expertise, having developed and delivered training for staff involved in research delivery at his trust. His prior experience on local and national committees further enriches the course content, providing insights into regulatory governance and best practices in clinical research.The curriculum covers a variety of essential topics, including an overview of Quality Assurance in clinical research, understanding the responsibilities of sponsors, sites, and staff, and preparing effectively for inspections or audits from regulatory bodies such as MHRA, EMA, and FDA. Participants will learn about the types of findings that can arise during inspections and the importance of implementing Corrective and Preventative Actions (CAPA) to enhance compliance and reduce errors in clinical trials. Additionally, the course emphasizes the importance of fostering a culture of continuous improvement and internal auditing within research teams.Attendees will also benefit from interactive discussions, breakout sessions, and Q&A segments, allowing them to engage actively with the content and share experiences with peers. The course aims to provide actionable takeaways, empowering participants to apply learned strategies in their roles effectively. A certificate for Continuing Professional Development will be issued to each participant who completes the course, recognizing their commitment to ongoing professional development.The event is suitable for a wide audience, including Heads and Directors of Research, Research Managers and Development Managers, Trial Coordinators, and Clinical Research Nurses. The online format encourages participation from a broad geographical reach, including audiences from Canada and the USA, making it a valuable opportunity for collaboration and networking among clinical professionals across borders. Participants are invited to reserve their places early, as the course is in high demand. This training not only aims to enhance individual competencies but also aspires to contribute to the overall improvement of clinical research practices within participating organizations.