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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems.
Data collection or data gathering is the process of gathering and measuring information on targeted variables in an established system, which then enables one to answer relevant questions and evaluate outcomes. Data collection is a research component in all study fields, including physical and social sciences, humanities, [2] and business ...
A research design typically outlines the theories and models underlying a project; the research question(s) of a project; a strategy for gathering data and information; and a strategy for producing answers from the data. [1] A strong research design yields valid answers to research questions while weak designs yield unreliable, imprecise or ...
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.
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 ...
Accurate data collection is essential to many business processes, [6] [7] [8] to the enforcement of many government regulations, [9] and to maintaining the integrity of scientific research. [10] Data collection systems are an end-product of software development. Identifying and categorizing software or a software sub-system as having aspects of ...
Quantitative research using statistical methods starts with the collection of data, based on the hypothesis or theory. Usually a big sample of data is collected – this would require verification, validation and recording before the analysis can take place. Software packages such as SPSS and R are typically used for this purpose. Causal ...