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IPSG.1 Identify Patients Correctly; IPSG.2 Improve Effective Communication; IPSG.3 Improve the Safety of High-Alert Medications; IPSG.4 Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery
Medical audit later evolved into clinical audit and a revised definition was announced by the NHS Executive: "Clinical audit is the systematic analysis of the quality of healthcare, including the procedures used for diagnosis, treatment and care, the use of resources and the resulting outcome and quality of life for the patient."
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
With the variance on the number of references that can be made for adverse event terms or medication names, standard dictionaries of these terms can be loaded into the CDMS. The data items containing the adverse event terms or medication names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare them ...
Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with local, regional, national, or international laws and regulations. This includes ongoing collection of safety data after a product is approved for marketing.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
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Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.