Electronic data capture is a technological innovation brought about by the rigor of clinical studies. These studies often rely on the exact and timely capture data. While paper-based data collection could suffice for small scale studies without many variables, it becomes impractical for more complex instances. Often, paper-based systems increase the cost and time needed to complete the trials.
During the 1990s, a new system of capturing data evolved. This is the RDC or Remote Data Capture. These systems used to be difficult to operate, since they often use specialized devices. This is unlike the commonplace desktop computer.
RDCs do not allow you to easily interchange the data with another system. The system was inflexible and needed improvement. Due to this, EDC was developed. Today, it has been adopted by an increasing number of clinical trials.
What is Electronic Data Capture (EDC)?
Essentially, an EDC is a software program that stores the information collected in clinical trials. It is an important component of clinical data management, since it is used in all phases of a clinical trial — from collecting to reporting data. Check out the video below to learn more:
EDCs offer a number of advantages over regular pen-and-paper record keeping. Among them are the following:
– Faster Data Access. EDCs allow for real-time data access. This reduces the time needed in processing queries. At the end of a clinical trial, it also saves time by immediately making the data available for your analysis.
– Secure Data Storage. Some clinical studies involve the collection of sensitive information from patients. EDCs allow for a secure clinical trial management system by giving you data encryption options. Because only certain people have access credentials to the data, only authorized staff can view the information. Many clinical trial software vendors also offer back up services to ensure continuous availability in case of system issues.
– Accuracy and organization. You can configure EDC forms to accept only certain values, avoiding illogical or inaccurate values from being entered. This makes for a cleaner database. The built-in search can be used to quickly find the data you need. The user-friendly interface allows for better navigation than stacks of paper.
– Cost Effectiveness. EDCs, just like many eClinical solutions, range from free and open source to very expensive. There are also additional features that may be bought independently from the vendors. EDCs are investments that should save the clinic money in the long run by making its processes more efficient.
EDC Trends in Clinical Data Management
In advanced countries across the world, EDCs are being widely adopted. In Canada, for example, 41% of the clinical trials surveyed were already using and EDC system back in 2009. These were concentrated in larger trials and those sponsored by the industry.
In developing countries, impediments to EDC adoption are also being addressed by technology. For example, a survey indicated that nearly 60% of healthcare practitioners are averse to entering data into an EDC in front of a patient. This is partly due to the pen-and-paper based workflow that these practitioners prefer.
To counter this, EDC systems are already available through various point-of-contact information collection systems. These systems simulate the pen-and-paper motion. Examples include tablet PCs and digital pens. These systems interface with the clinical trial management software and the EDC, providing a seamless experience.
You can also integrate an EDC with other types of software used in the modern clinic. These include supply management software and adverse event reporting tools. The EDC allows you to quickly import electronic data from one resource to another. You can capture data from laboratory reports and electronic health records, as well as from imaging data sources.
Because of the availability of Electronic Data Capture software, standards have also been set in place. These ensure that they have available technical controls for ensuring the integrity of data. For example, Title 21 of the Code of Federal Regulations mandates specific requirements for EDCs. Standard operating procedures are also kept in place to ensure that requisite policies are met.
Another trend is concerned with the rise of independent standards for sharing data. One example is CDISC, which encourages the inter-operability of clinical research data. The promotion of a vendor-neutral and platform-independent environment allows for a freer exchange of information related to medical research. Following a CDISC standard, you can acquire and access clinical trial information from another study regardless of the systems used.
The Future of Clinical Data Solutions
EDCs have immense potential. Just as the Internet links todays world, EDCs could potentially unify the scene of clinical trials. Information could be immediately stored, sorted, and viewed by those who have access.
From here, the information can be exported and processed. The results can then be shared for use in future trials. Such unprecedented synergy enabled by technology can be a major driving force in improving the global healthcare scene.
CDISC mission and principles. (2016, August 1). Retrieved September 2, 2016, from http://www.cdisc.org/about/mission
CFR – code of federal regulations title 21. (2015, January ). Retrieved September 2, 2016, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
Emam, K. E., Jonker, E., Sampson, M., Krlea-Jeric, K., & Neisa, A. (2009). The use of electronic data capture tools in clinical trials: Web-survey of 259 Canadian trials. Journal of Medical Internet Research, 11(1), 8. doi:10.2196/jmir.1120
Parekh, S. (2013). Electronic Data Capture in Clinical Trials. Retrieved September 2, 2016, from Applied Clinical Trials, http://www.appliedclinicaltrialsonline.com/electronic-data-capture-clinical-trials