Improvements In Data Quality Of Clinical Data Management Systems Brought About By The Use Of Electronic Data Capture Software
Electronic data capture (EDC) makes clinical research better nowadays. Although clinical studies were done centuries before, the first proper clinical study was only performed in the 1700s. While there was no medical data collection done before this time, observations and results were written in paper.
Clinical studies are an important tool for research. They help advance medical knowledge and patient care. Without properly recorded data, the medical community cant develop new drugs and treatment methods.
As a user, you are able to collect important data from clinical studies using various tools offered by EDC systems (Schwartz, 2014). These tools enable you to improve the way you analyze data and report high quality results. It also speeds up your documentation process of clinical studies wherever relevant. Taking advantage of these capabilities in turn, not only results in time savings, but can also positively affect a countrys economy.
In the United States, the National Institutes of Health Director Dr. Francis Collins led the completion of the Human Genome Project to map the human DNA. It was one of the best examples of a clinical trial that had a high return of investment (ROI). From a budget of just $4 billion, it generated an economic growth that translated to $796 billion in its first decade alone.
Data Quality in Clinical Data Management
The advantages brought by EDC makes it imperative for users like you to provide high quality clinical data. The concern however, as raised by Alsumidaie and Andrianov (2015), is the lack of data quality definitions and standards. As a result, data is considered inaccurate (no data integrity) and becomes invalid (no data consistency), thus losing its quality.
Aside from this concern, Alsumidaie and Andrianov (2015) points out the risks of using data wholly recorded on paper. The two cited an example of data being incorrectly recorded and thus misinterpreted.
The Use of EDC Software as eClinical Solutions
While clinical data management standards have to be efficiently defined and managed, clinical trial software such as an EDC system is an important research tool that helps improve data quality.
What Is an EDC?
Electronic Data Capture is a general term used to describe the process of recording clinical trial data in electronic form. Typically, you record data on paper first, transcribe it in an EDC, and then save it as an electronic case report form (eCRF). Check out the video below to learn more:
Before the 1990s, EDC operated as Remote Data Entry (RDE) software. Users were provided with a computer or laptop that had the software in it. Whereas data were forwarded to clinical trial sponsors before, you can now immediately record and check clinical study data. Fortunately, because of usability, cost, and hardware issues caused by RDE, EDC was born.
Features Offered by Clinical Data Solutions
The introduction by the U.S. Food and Drug Administration (FDA) of the Critical Path Initiative (CPI) in March 2004 motivated EDC software developers to add important features in their products (Babre, 2011). Newly developed features you can look forward to include:
– Compliance with regulatory standards
– Prevention of unauthorized access to data
– Appropriate tools based on user role
– Application of electronic signature
– Detection of fraudulent data
While these are special, other common features include:
– eCRF designer, so you can create different kinds of forms that you commonly use across different studies
– Data entry, so you can automatically record data
– Query management, so your EDC can communicate with other clinical trial management software operated by other users
– Data export, so you can extract patient data
Collectively, these features enable EDC systems to provide high quality clinical research data. As a result, more clinical trials are now using EDC as compared to those still using the traditional, paper-based method, which is error-prone and time-consuming (Walther, Hossin, Townend, Abernethy, Parker, & Jeffries, 2011).
Enjoying the Benefits of a Clinical Trial Management System
EDC can help you improve data quality by providing consistency and accuracy.
Data consistency is the most important part of conducting research. An EDC system with standard data collection tools and forms makes it easier for you to achieve this. A standardized data collection method eliminates user bias and other factors that could complicate results.
EDC systems can prevent you from entering inaccurate data by adding user constraints to the forms it provides. This improved data quality gives you cleaner data that has legible entries and automated calculations.
Electronic data capture enables you to improve data quality for your clinical trial record and results (Wilson, 2015). In addition, it provides cleaner data, faster access to results, and more efficient clinical data collection.
Schwartz, M. (2014, March 18). Data Quality in Electronic Data Capture Based Clinical Studies [eClinical Viewpoint Blog]. Retrieved from http://www.mednetstudy.com/data-quality-in-electronic-data-capture-based-clinical-studies/
Alsumidaie M., & Artem Andrianov A. (2015, March 19). How Do We Define Clinical Trial Data Quality if No Guidelines Exist? [Applied Clinical Trials]. Retrieved from http://www.appliedclinicaltrialsonline.com/how-do-we-define-clinical-trial-data-quality-if-no-guidelines-exist
Babre, D. (2011). Electronic data capture Narrowing the gap between clinical and data management. Perspective in Clinical Research, 2(1), 13. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3088950/
Walther, B., Hossin, S., Townend, J., Abernethy, N., Parker, D., & Jeffries, D. (2011). Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data. PLOS One, 6(9), e25348. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3179496/
Wilson, A. (2015 March 11). Benefits, Challenges and Best Practices of Clinical Trials: Paper vs. Electronic Data Capture. Open Health News. Retrieved from http://www.openhealthnews.com/story/2015-03-11/benefits-challenges-and-best-practices-clinical-trials-paper-vs-electronic-data-cap