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, electronic data capture 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...
The aspect of the quality of the data created plays a fundamental role in the result of the research study (Krishnankutty et al., 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. Electronic data capture has a significant impact on the roles and responsibilities of the clinical…
