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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.
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
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]
Audit certificate A declaration of confirmation by the auditor that an audit has taken place. (ICH E6) Audit report A written evaluation by the sponsor's auditor of the results of the audit. (ICH E6) Audit trail Documentation that allows reconstruction of the course of events. (ICH E6)
ISA 230 Audit Documentation is one of the International Standards on Auditing.It serves to direct the documentation of audit working papers in order to assist the audit planning and performance; the supervision and review of the audit work; and the recording of audit evidence resulting from the audit work in order to support the auditor's opinion.
For example, it has been used to assess novel drugs, [37] models of clinical care, in audit of clinical services and in assessment of teledermatology. [36] The DLQI is the most widely used quality of life outcome measure in randomised controlled trials of therapies for psoriasis.
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An auditor's report is a formal opinion, or disclaimer thereof, issued by either an internal auditor or an independent external auditor as a result of an internal or external audit, as an assurance service in order for the user to make decisions based on the results of the audit.