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Medical audit later evolved into clinical audit and a revised definition was announced by the NHS Executive: "Clinical audit is the systematic analysis of the quality of healthcare, including the procedures used for diagnosis, treatment and care, the use of resources and the resulting outcome and quality of life for the patient."
An agreement between this entity and the Brazilian Institute for Excellence in Health allows the Andalusian certification model for hospitals and clinical management units to be exported to Brazil. CHKS Ltd is a specialist international provider of healthcare accreditation programmes based in the UK and accredited to ISQua and ISO 17021:2011 ...
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
The Joint Commission Accreditation for Healthcare Organization (JCAHO) is a nonprofit organization that assesses quality at multiple levels by inspecting health care facilities for adherence to clinical guidelines, compliance with rules and regulations for medical staff skills and qualifications, review of medical records to evaluate care ...
Article 58 requires that "the sponsor and investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial." This requirement defines a minimum retention period across the EU for all clinical trial master files, irrespective of whether the data subsequently supports a marketing ...
Clinical audit is the review of clinical performance, the refining of clinical practice as a result and the measurement of performance against agreed standards – a cyclical process of improving the quality of clinical care. In one form or another, audit has been part of good clinical practice for generations. Whilst audit has been a ...
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Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...