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Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
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]
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]
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
Health information management professionals plan information systems, develop health policy, and identify current and future information needs. In addition, they may apply the science of informatics to the collection, storage, analysis, use, and transmission of information to meet legal, professional, ethical and administrative records-keeping ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
A nursing care plan promotes documentation and is used for reimbursement purposes such as Medicare and Medicaid. The therapeutic nursing plan is a tool and a legal document that contains priority problems or needs specific to the patient and the nursing directives linked to the problems. It shows the evolution of the clinical profile of a patient.
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.