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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.
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 ).
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 ...
Most countries require that companies and organizations translate literature and labeling for medical devices or pharmaceuticals into their national language. Documents for clinical trials often require translation for local clinicians, patients, and regulatory representatives. Regulatory approval submissions typically must be translated.
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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The nursing care plan (NCP) is a clinical document recording the nursing process, which is a systematic method of planning and providing care to clients. [6] It was originally developed in hospitals to guide nursing students or junior nurses in providing care to client; however, the format was task-oriened rather than nursing-process-based. [8]