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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
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 ...
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. Systems for ...
Operational data stores established for extracting, transferring and loading before creating warehouse or data marts. [21] Clinical registries repositories have long been in existence, but their contents are disease specific and sometimes considered archaic. [21] Clinical data stores and clinical data warehouses are considered fast and reliable.
Health data can be used to benefit individuals, public health, and medical research and development. [14] The uses of health data are classified as either primary or secondary. Primary use is when health data is used to deliver health care to the individual from whom it was collected. [15]
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 ...
Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and ...
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.