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The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
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 ...
A data definition specification was produced by the Open Mobile Alliance to document charging data. [4] The document, the centralized catalog of data elements defined for interfaces, specifies the mapping of these data elements to protocol fields in the interfaces. Created for the exchange of financial data, Market Data Definition Language ...
Health information management's standards history is dated back to the introduction of the American Health Information Management Association, founded in 1928 "when the American College of Surgeons established the Association of Record Librarians of North America (ARLNA) to 'elevate the standards of clinical records in hospitals and other medical institutions.'" [3]
In the U.S. the CDA standard is probably best known as the basis for the Continuity of Care Document (CCD) specification, based on the data model as specified by ASTM's Continuity of Care Record. The U.S. Healthcare Information Technology Standards Panel has selected the CCD as one of its standards. [citation needed]
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
For example, a patient's name, date of birth, or a blood-test result can be recorded in a structured data format. Unstructured health data, unlike structured data, is not standardized. [4] Emails, audio recordings, or physician notes about a patient are examples of unstructured health data.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.