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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.
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 ...
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.
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.
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 ...
In addition, they may apply the science of informatics to the collection, storage, analysis, use, and transmission of information to meet legal, professional, ethical and administrative records-keeping requirements of health care delivery. [1] They work with clinical, epidemiological, demographic, financial, reference, and coded healthcare data.
Most HEDIS data is collected through surveys, medical charts and insurance claims for hospitalizations, medical office visits and procedures. Survey measures must be conducted by an NCQA-approved external survey organization. Clinical measures use the administrative or hybrid data collection methodology, as specified by NCQA.
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.