Clinical Electronic Data Capture (EDC) System

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A Clinical Electronic Data Capture (EDC) System is a domain-specific data capture system that can support a clinical EDC task (for collecting clinical data in electronic format).



References

2022

2021a

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Electronic_data_capture Retrieved:2021-12-5.
    • QUOTE: 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. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).

      Typically, EDC systems provide:

    • EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC can increase data accuracy and decrease the time to collect data for studies of drugs and medical devices. The trade-off that many drug developers encounter with deploying an EDC system to support their drug development is that there is a relatively high start-up process, followed by significant benefits over the duration of the trial. As a result, for an EDC to be economical the saving over the life of the trial must be greater than the set-up costs. This is often aggravated by two conditions: #that initial design of the study in EDC does not facilitate the decrease in costs over the life of the study due to poor planning or inexperience with EDC deployment; and #initial set-up costs are higher than anticipated due to initial design of the study in EDC due to poor planning or experience with EDC deployment. The net effect is to increase both the cost and risk to the study with insignificant benefits. However, with the maturation of today's EDC solutions, much of the earlier burdens for study design and set-up have been alleviated through technologies that allow for point-and-click, and drag-and-drop design modules. With little to no programming required, and reusability from global libraries and standardized forms such as CDISC's CDASH, deploying EDC can now rival the paper processes in terms of study start-up time. As a result, even the earlier phase studies have begun to adopt EDC technology.
  1. Hamad, F. (2017). "Chapter 13: Health information systems: Clinical data capture and document architecture". In Urquhart, C.; Hamad, F.; Tbaishat, D.; Yeoman, A. (eds.). Information Systems: Process and Practice. Facet Publishing. pp. 233–53. ISBN 9781783302413. Retrieved 24 May 201

2021b

RDE software was started in the mid- to late-1980s as software installed locally on portable computers with modems. It has largely been replaced by a newer generation of software called electronic data capture, or EDC, that provides the same type of functionality over the Internet using web pages.

2021c

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_data_acquisition Retrieved:2021-12-12.
    • QUOTE: 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.

      There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.

      The ICH guidelines on good clinical practice (GCP) use the term ‘case report form’ (CRF) to refer to these systems. No matter what CRF is utilized, the quality and integrity of the data is of primary importance.

2016

2011

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