Emerging trends in Electronic Data Capture :: Integration of EDC with eSource from EHR systems at sites

Aug, 2008. By Callum Bir

Increasingly clinical trials are coming under the regulatory lense because of lack of necessary accounting of the patient and drug effects information. The following article takes a look at the new trends in electronic data capture that help track the data better.

The adoption of electronic medical records (EMRs) in both hospitals and private practice is on a steady incline. Alongside the growth in EMR, Electronic Data Capture (EDC) systems are today used in an estimated 30-35% of clinical trials, again in both hospitals and private practices. The use of electronic data capture technologies provides the opportunity to significantly enhance clinical trial conduct through improved efficiency and accuracy, as well as the potential for real-time response to possible adverse situations. The data captured in clinical trial systems may be based upon a prior electronic source (eSource), such as EMR. Unfortunately, many of the EMR systems that manage the electronic source today cannot be used reliably for clinical research purposes because of the variability among these systems and the fact that they are not required to meet regulatory requirements for clinical trials. Therefore the data that are in the EMR system have to be printed or hand-transcribed and re-entered into the EDC system. The duplication of tasks, generation of paper and associated costs and inefficiencies, will only grow with the increasing use of electronic data sources. With the transformation in healthcare data collection migrating from a paper world to an EDC one, the scenario begs the question, "How can EDC integrate with these systems at sites and avoid redundant data collection?"

The eClinical Forum (www.eclinicalforum.com) and PhRMA EDC/eSource taskforce is very active in formulating standards around integrating aspects of clinical trial data with healthcare data. This article has reference to many of the survey work and visionary publications of these groups.

(Read more http://ehealthonline.org/articles/article-details.asp?Title=Emerging-trends-in-Electronic-Data-Capture&ArticalID=2071&Type=ZOOM%20IN )