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The clinical audit process seeks to identify areas for service improvement, develop & carry out action plans to rectify or improve service provision and then to re-audit to ensure that these changes have an effect. Clinical audit can be described as a cycle or a spiral, see figure.
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
The Alcohol Use Disorders Identification Test (AUDIT) is a ten-item questionnaire approved by the World Health Organization to screen patients for hazardous (risky) and harmful alcohol consumption. It was developed from a WHO multi-country collaborative study, [ 1 ] [ 2 ] [ 3 ] the items being selected for the AUDIT being the best performing of ...
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. [8] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. [9]
Nevertheless, case reports do have genuinely useful roles in medical research and evidence-based medicine. [4] In particular, they have facilitated recognition of new diseases and adverse effects of treatments [ 5 ] (e.g., recognition of the link between administration of thalidomide to mothers and malformations in their babies was triggered by ...
This consists of more than 40 clinical audits, registries and confidential enquiries that cover a range of health conditions. 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.
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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 ...