Electronic Data Capture
What are the most important ways that EDC affects the conduct of a clinical trial?
Electronic Data Capture (EDC) takes into account an increasing series of alternatives for gathering clinical trial data. EDC facilitates the direct data entry into an electronic system, devoid of the hassle of labor-intensive record and succeeding data entry (Lindquist, 2013). With the advancement of technology, has replaced the collection of data on paper and presently collects clinical data in an electronic manner. This method of data collection has come to be prominent and beneficial to clinical trials (Clinovo, 2013). There are significant ways in which EDC influences the conduct of a clinical trial. For starters, electronic data capture systems offer a consistent and uniform approach for data gathering that diminishes use bias and other confounding elements that could impact results (Lindquist, 2013). One of the significant influences of EDC on clinical trials is efficiency. It is imperative to note that time constraints is always an issue when conducting clinical trials and managing the resources involved. These challenges may be resolved through the utilization of EDC. Owing to EDC, the time spent on a clinical trial is not particularly impacted and the workload is reduced (Lindquist, 2013).
A clinical trial is purposed to attain answers and solutions to the research question being considered by means of creating data for substantiating or refuting a hypothesis. The aspect of the quality of the data created plays a fundamental role in the result of the research study (., 2012). Another important element is patient safety. In particular, EDC improves the quality of data, enhances reactivity, and decreases time for studying or researching the clinical question. This in turn can contribute to the quick delivery of better outcomes in the clinical trials. A number of particular EDC elements have an even considerable influence. For instance, this can be through the quick notification of disparaging events in the sense that it can facilitate faster and better decision making and can save patients (Clinovo, 2013).
How does EDC affect the role and responsibility of a CRA?
The Clinical Research Associate (CRA) has the key role and responsibility of sensibly choosing suitable investigators, prompts and observes the clinical trials at the dissimilar sites and, monitors the progression of the study, up until the finishing point. has a significant impact on the roles and responsibilities of the clinical research associate (CRA). For starters, owing to the institution of EDC, the role and responsibilities of data entry and data variation are taken from data managers and thereafter given to the clinical research associate (Medidata, 2013). In particular, these duties and accountabilities are given to the CRA with the intent of allowing data managers to lay emphasis and focus on activities within the clinical trial that are more value-added. More so, the clinical research associate is also given the significant responsibility of extensively and efficaciously making preparation for monitoring visits and conduct data assessment and review between visits. The additional impact and change in responsibility of the CRA, owing to EDC, is making sure that clinical trial site visits are assured to be effective and steadfast (Medidata, 2013). The CRA has a role that is impelled by the use of the electronic data collection (EDC) system. This is in consequence of the fact that it takes into account the role of crafting manual queries for the electronic data collection system, , in addition to the augmented accountability for measuring the retorts accomplished from the queries (O’Shaughnessy, 2007).
References
Clinovo. (2013). Challenges and benefits of EDC adoption. Retrieved 23 January 2016 from:http://www.clinovo.com/blog/challenges-and-benefits-of-edc-adoption/
Krishnankutty, B., Bellary, S., Kumar, N. B., & Moodahadu, L. S. (2012). Data management in clinical research: an overview. Indian journal of pharmacology, 44(2), 168.
Lindquist, A. (2013). Advantages of EDC Over Other Methods for Data Capture. Forte Research. Retrieved 23 January, 2016 from: http://forteresearch.com/news/advantages-of-edc-over-other-methods-for-data-capture/
Medidata. (2013). Capturing the Value of EDC. Medidata Solutions, Inc. Retrieved 23 January 2016 from: https://www.mdsol.com/sites/default/files/RAVE_Capturing-Value-EDC_20131130_Medidata_White-Paper.pdf
O’Shaughnessy, I. (2007). . eClinical. Retrieved 23 January 2016 from: https://www.iconplc.com/icon-files/docs/thought-leadership/public/Strategic-Interaction-Approaching-eClinical-as-a-New-Philosophy-for-Trial-Management.pdf
