Electronic Data Capture (EDC) is increasingly used across the world as the preferred means of recording clinical trial results. The system evolved from the RDC or Remote Data Capture system of the 1990s. During their time, RDCs were difficult to use. Check out the video below to learn more:
They often required extensive training when using the specialized devices. Today, the wide availability of computers made for a more universally accessible tool.
While some studies still use pen-and-paper recording and analysis, this is not advisable for larger setups. Clinical research is usually rigorous, relying on the timely and exact capture of important data.
After capture, several stages of processing are involved. Manual processes increase your margin for error. Also, both RDCs and pen-and-paper systems do not allow for easy interoperability between different systems and studies. The EDC addresses this concern.
What is the EDC?
The EDC is a type of software, which stores the data collected and processed during clinical trials. It plays an important part in clinical data management. It is important in different parts of the trials, since it provides you a facility for information input.
It also allows for a means to process and report this information easily. EDCs have a lot of advantages over the usual manual operations. These include the following:
Ease of Access - Getting the data is as easy as entering keywords into the system. When configured, EDCs allow for real-time access and monitoring. Upon the completion of trials, an EDCs interface also allows easy access of data for analysis.
Security - EDCs are often credential-based, letting only those with proper access look into the database. This protects the privacy of any person involved in the study.
Encryption measures can also be in place to avoid compromising the clinical trial management system. Unlike pen-and-paper systems, EDCs can also back the data up in remote servers.
Clinical trial software often allows this option for a secure upload to the cloud, without reducing the availability of data. This makes sure no data is lost even if your primary database is corrupted.
Cleanliness of data - Erroneous and irrelevant data may sometimes end up in manual processes due to the different ways individual researchers interpret entry fields.
In an EDC, the input may be restricted only to a specific set of values. This also allows the interface to search through all your records at a moments notice.
Cost - Just like most eClinical solutions, EDCs can range from the expensive, enterprise solutions to the free, open-source projects. The type of EDC installed depends on your requirements, but any expense in this part will be an investment in the efficiency of clinical processes.
Trends in the EDC and in Clinical Data Management
Especially in technologically advanced countries, EDC has been widely adopted across the world. For example, Canada has been using EDCs in more than 41% of its clinical trials. This was just back in 2009.
Most of the studies reported using an EDC are those in larger-scale, industry-related studies.
In most developing regions, one of the major blockers of EDC adoption is the workflow. Most practitioners are used to working with the pen-and-paper systems they have been using for so long.
In fact, a study found out that more than half of the practitioners consider it improper to enter data into EDCs while still conversing with the patient.
To get past this, newer EDCs are adopting pen-and-paper like devices such as digital pens, tablets, and the like. This allows for a modernized point-of-contact system without compromising workflow.
EDCs can also be connected with other clinical trial management software to ensure a synergized setup. Adverse event reporting tools, supply management software, and similar others can be synced. Data can also be imported from one resource to another.
Because Electronic Data Capture software are already being widely adopted, standards have also cropped up to regulate their use. Such standards enforce technical controls to ensure your datas integrity.
For example, the Code of Federal Regulations mandate a set of requirements for EDCs under Title 21.
Another trend is the appearance of independent data sharing standards. One of the most prominent is the CDISC. The standard encourages the interoperability of information, spanning different software that handle clinical research data.
The standard promotes a platform-independent and a vendor-neutral environment to allow for better information exchange. If your EDC follows the CDISC standard, clinical trial information can be accessed from a different study -- even if it uses a different system.
Clinical Data Solutions -- Evolving
While the immense potential of EDCs has not yet been fully realized, it is growing close. It is poised to be the Internet of the healthcare world, allowing the fast, accurate and unlimited transfer of information. This data can then be processed at any time.
The results of the processes can be exported, then imported by another study. Such a setup allows researchers to build up from the works of others easily by getting their raw data directly.
This technology has the potential to change the global healthcare scene by inviting more participation and synergy from its many components.
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