Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into ‘building blocks’ that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.
This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry.
- Uses practice-based evidence for developing and delivering quality assurance and management systems
- Includes case studies associated with ‘failures’ and ‘lessons learned’
- Discusses clinical trials in academic, clinical and industry settings
- Demonstrates how to build resilience into systems that could evolve to promote best practices, even with limited resources
- Compares and contrasts different QA/QC practices
1. Introduction2. Building a QMS focused on clinical specialties3. Audits and Monitoring4. Inspections5. Case studies
Gayathri Delanerolle is a Researcher. Her interests include women's health, artificial intelligence and chronic conditions with a special focus on disease sequalae. She has experience in evidence synthesis, epidemiology and mixed-methods research. Gayathri's experience in quality assurance inspired her to develop the content for this book and co-author with others with a special focus on complex healthcare areas that are rapidly evolving.
Evette Sebastien Roberts is a practising nurse and midwife in London, England. Evette has been pivotal in assisting healthcare organisations to better understand the principles of governance and quality assurance, leading them in achieving compliance during accreditation and audit programmes. Her passion for risk management in healthcare has propelled her into seeking a number of roles; some of which include; Risk Midwife, Clinical Governance Manager and Regulatory and Compliance Lead. Having undertaken several inspections for the Care Quality Commission, Evette has knowledge and experience in what good looks like and the factors which often impinge on the ability to match required standards. In addition to her clinical roles, Evette has embarked on a research journey, seeking to contribute new knowledge on the subject matter of midwives experiences working with risk management frameworks. It is her enthusiasm for quality assurance which drives her appetite for research into this area which encompasses the patient safety agenda. Dr. Athar Haroon is a Consultant Radionuclide Radiologist and has worked in an array of NHS organisations and academia, including United Lincolnshire Hospitals NHS Trust, University of Leicester, University Hospitals of Leicester NHS Trust, Nottingham University Hospitals NHS Trust, University College London Hospitals NHS Foundation Trust and University College London respectively. He has a special interest in hybrid imaging and utility of biomarkers for diagnosis, disease management and treatment of a variety of clinical areas including Neurology, Oncology, Endocrinology and Emergency Medicine. He has experience working with several biomarkers such as 18F FDG, 18F Choline, Ga 68 PSMA, Ga68 DOTATATE, and 18F Amyloid. Dr Shetty trained at Cambridge University Hospitals and underwent a clinical fellowship in pain management at Guys & St Thomas Hospital in London. He is a consultant in pain medicine at University College London Hospitals and Associate Professor at UCL. His private practice is located at Harley Street Clinic and London Bridge Hospital. His special interests relating to chronic pain include neuromodulation, spinal cord stimulators, sports medicine, pelvic pain, and CRPS.
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