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Their purpose is to engage clinicians in systematic evaluation of their clinical practice against standards (often set by NICE), and to encourage improvement in the quality of care. This programme is gradually being extended to other areas of healthcare, working with clinical, patient and professional advisory groups.
It had been formally incorporated in the healthcare systems of a number of countries, for instance in 1993 into the United Kingdom's National Health Service (NHS), and within the NHS there is a clinical audit guidance group in the Clinical audit comes under the clinical governance umbrella and forms part of the system for improving the standard ...
NICE publishes guidelines in four areas: the use of health technologies within England's National Health Service (NHS) (such as the use of new and existing medicines, treatments and procedures) clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions)
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 ...
A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine
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 ...
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year-old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration.