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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 ...
The cells will be delivered in immunoprotective capsules and pre-clinical results in animal models showed remission of symptoms within a few months. [16] The company reported the successful transplantation of the cells in the first of the 40 patients that will be treated under the trial in late October 2014. [17]
Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field.
Gene expression profiling is a technique used in molecular biology to query the expression of thousands of genes simultaneously. While almost all cells in an organism contain the entire genome of the organism, only a small subset of those genes is expressed as messenger RNA (mRNA) at any given time, and their relative expression can be evaluated.
This data typically includes a record of services received, conditions of those services, and clinical outcomes consequent of those services. [2] For example, a blood draw may be a service received, a white blood cell count may be a condition of that service, and a reported measurement of white blood cells may be an outcome of that service.
The Liver Imaging Reporting and Data System (aka LI-RADS) is a quality assurance tool created and trademarked by the American College of Radiology in 2011 to standardize the reporting and data collection of CT and MR imaging patients at risk for hepatocellular carcinoma (HCC), or primary cancer of the liver cells. [1]