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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.
Forms processing is a process by which one can capture information entered into data fields and convert it into an electronic format. This can be done manually or automatically, but the general process is that hard copy data is filled out by humans and then "captured" from their respective fields and entered into a database or other electronic format.
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 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.
Capturing data can be done in various ways; the best method depends on application. In biometric security systems, capture is the acquisition of or the process of acquiring and identifying characteristics such as finger image, palm image, facial image, iris print, or voiceprint which involves audio data, and the rest all involve video data.
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However most of the instruments in current use have been validated in paper form, and we need to ask (1) whether the paper data can be used to establish validity of the electronic version, and (2) whether data from paper and electronic versions can be used interchangeably.