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A Clinical Data Repository (CDR) or Clinical Data Warehouse (CDW) is a real time database that consolidates data from a variety of clinical sources to present a unified view of a single patient. It is optimized to allow clinicians to retrieve data for a single patient rather than to identify a population of patients with common characteristics ...
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
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).
XDS uses structured EHR standards such as Continuity of Care Record (CCR) and Clinical Data Architecture (CDA) to facilitate data exchange. [2] The registry stores metadata about each document stored in a repository, including its source or location. [3] There may be multiple repositories of documents indexed, [4] but only one registry per ...
The use of real-world data from electronic health records and digital health-monitoring devices is also given as an example of general Post-Market Clinical Followup (PMCF) information for medical devices in the guideline "MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)" from December 2022.
The information contained in the medical record allows health care providers to determine the patient's medical history and provide informed care. The medical record serves as the central repository for planning patient care and documenting communication among patient and health care provider and professionals contributing to the patient's care.
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 ...
Context management is the process of using particular "subjects" of interest (e.g., user, patient, clinical encounter, charge item, etc.) to virtually link disparate applications so that the end-user sees them operate in a unified, cohesive way. Context management can be utilized for both CCOW and non-CCOW compliant applications.