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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.
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.
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 ...
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]
In the second report for the Department of Health, Fiona Caldicott wrote that: . The use of personal confidential data for local clinical audit is permissible within an organisation with the participation of a health and social care professional with a legitimate relationship to the patient through implied consent.
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.
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]
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.