Electronic data capture
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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.
Typically, EDC systems provide:
- a graphical user interface component for data entry
- a validation component to check user data
- a reporting tool for analysis of the collected data
EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research,[1] but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance, although some EDC system's such as SciAn Services edcpro are specialized to include tools for phases I-II.
EDC can increase the 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: 1) 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 2) 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.
History
EDC is often cited as having its origins in another class of software — Remote Data Entry (RDE) that surfaced in the life sciences market in the late 1980s and early 1990s. However its origins actually begin in the mid 1970s with a contract research organization known then as Irovided reports to Abbott.
Clinical research data—patient dathen sent to the research sponsor (e.g., a pharmaceutical company) for data entry into a database and subsequent statistical ats by sponsors is delayed
These early RDE systems used "nection oven analog phone line to periodically transmit the data back to the sponsor, and to collect questions from the sponsor that the medical staff would need to answer.
Though effective, e deployed, insta this model resulted in a proliferation of laptop computers at many investigational sites that participated in more than one research study simultan the investigational sites. EDC represents this new class of software. .[2]
Current landscape
The EDC landscape has continued to evolve from its evolution from RDE in the late 1990s, and today the market consists of a variety of new and established software providers.
In addition to pure software companies; pharmaceutical, biotech and contract research organizations have developed their own EDC systems (ex: e-SOCDAT, edcpro).
The future of EDC
As EDC software continues to mature, vendors are including capabilities that would have previously been developed and sold as separate software solutions: clinical data management systems (CDMS), clinical trial management systems (CTMS), business intelligence and reporting, and others. This convergence is expected to continue until electronic patient medical records become more pervasive within the broader healthcare ecosystem -- at which point the ideal solution would be to extract patient data directly from the electronic medical records as opposed to collecting the data in a separate data collection instrument. Standards such as CDISC and HL7 are already enabling this type of interoperability to be explored.
See also
- Clinical data acquisition
- Clinical Data Management System (CDMS)
- Case Report Form (CRF)
- Remote Data Entry (RDE)
- Remote Data Capture (RDC)
- Patient-reported outcome (PRO)
- Data Capture Software - a technological system for scanning and capturing information from paper forms
- Title 21 CFR Part 11
- SmartPen - a technological system for digitally encoding and transmitting CRFs
References
- ^ David Handelsman. "Electronic Data Capture: When Will It Replace Paper?". SAS Institute Inc. Retrieved 2010-09-03.
{{cite web}}: Italic or bold markup not allowed in:|publisher=(help) - ^ IBM (1956). Data Capture. 22-5526-4.