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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
The use of Clinical Data Repositories could provide a wealth of knowledge about patients, their medical conditions, and their outcome. The database could serve as a way to study the relationship and potential patterns between disease progression and management. The term "Medical Data Mining" has been coined for this method of research.
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 ...
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]
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 care analytics is the health care analysis activities that can be undertaken as a result of data collected from four areas within healthcare: (1) claims and cost data, (2) pharmaceutical and research and development (R&D) data, (3) clinical data (such as collected from electronic medical records (EHRs)), and (4) patient behaviors and preferences data (e.g. patient satisfaction or retail ...
A case series in which the patients receive treatment in a clinic or other medical facility. (NCI) Clinical study or Clinical trial. A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial. (NCI)
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 ...