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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.
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 ...
Clinical peer review, also known as medical peer review is the process by which health care professionals, including those in nursing and pharmacy, evaluate each other's clinical performance. [ 1 ] [ 2 ] A discipline-specific process may be referenced accordingly (e.g., physician peer review , nursing peer review ).
An XML element in a CDA supports unstructured text, as well as links to composite documents encoded in pdf, docx, or rtf, as well as image formats like jpg and png. [ 3 ] It was developed using the HL7 Development Framework (HDF) and it is based on the HL7 Reference Information Model (RIM) and the HL7 Version 3 Data Types.
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [ 1 ]
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Continuity of Care Document - The Continuity of Care Document (CCD) represents a core data set of the most relevant administrative, demographic, and clinical information facts about a patient's healthcare, covering one or more healthcare encounters. The primary use case for the CCD is to provide a snapshot in time containing the germane ...