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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
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.
Health informatics, which is broadly defined as the collection, storage, distribution, and use of health data, differs from medical informatics in its use of information technology. [ 5 ] Individuals are the origin of all health data, yet the most direct if often overlooked is the informal personal collection of data.
Application: the purpose for which the data are collected. Collection: the processes by which data elements are accumulated. Warehousing: the processes and systems used to store and maintain data and data journals. Analysis: the process of translating data into information utilized for an application.
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 ...
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 ...
Clinical measures use the administrative or hybrid data collection methodology, as specified by NCQA. Administrative data are electronic records of services, including insurance claims and registration systems from hospitals, clinics, medical offices, pharmacies and labs. For example, a measure titled Childhood Immunization Status requires ...
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.