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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.
According to AHIMA's Data Quality Management Model, there are four key processes for 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.
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.
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 ...
The terms EHR, electronic patient record (EPR), and electronic medical record (EMR) have often been used interchangeably, but "subtle" differences exist. [6] The electronic health record (EHR) is a more longitudinal collection of the electronic health information of individual patients or populations.
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
NCHS collects data from birth and death records, medical records, interview surveys, and through direct physical examinations and laboratory testing. These diverse sources give perspectives to help understand the U.S. population's health, health outcomes, and influences on health. [8] There are four major data collection programs at NCHS:
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.