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The National Institute for Health and Clinical Excellence (NICE) published the paper Principles for Best Practice in Clinical Audit, [1] which defines clinical audit as "a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change.
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The AUDIT consists of ten questions, all of which ask explicitly about alcohol: Questions 1 to 3 ask about consumption of alcohol (frequency, quantity or typical drinking occasions, and consumption likely to cause impairment); Possible dependence on alcohol (Questions 4 to 6), and
Medical audit is a focused study of the process and/or outcomes of care for a specified patient cohort using pre-defined criteria. Audits are typically organized around a diagnosis, procedure or clinical situation. [28] [29] It remains the predominant mode of peer review in Europe [30] and other countries. [31] [32]
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 significant event audit (SEA), also known as significant event analysis, is a method of formally assessing significant events, particularly in primary care in the UK, with a view to improving patient care and services. To be effective, the SEA frequently seeks contributions from all members of the healthcare team and involves a subsequent ...
For audits performed by an outside audit firm, risk assessment is a crucial stage before accepting an audit engagement. According to ISA315 Understanding the Entity and its Environment and Assessing the Risks of Material Misstatement , "the auditor should perform risk assessment procedures to obtain an understanding of the entity and its ...
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 ...