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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…
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). Strategic Interaction. 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
Operational Data Systems There are several systems and technologies commonly used to manage operational data. These tools accessible for data management are referred to as Clinical Data Management Systems (CDMS). The commonly used tools include: CLINTRIAL, ORACLE CLINICAL, RAVE, MACRO and also eClinical Suite (Krishnankutty et al., 2012). With regard to functionality, these software technologies are relatively comparable and there is no substantial lead of one system set against the other.
research database be part of the protocol development team. Perhaps the most eminent of these reasons pertains to the need to have the data collection process aligned with the efforts of the protocol development team. The sort of congruence that needs to exist between database collection and protocol development is essential to ensuring that the data that is captured for analysis directly relates to the research study as a
Monitoring Why is it important for the CRA to understand the data management and statistical analysis plans? What exceptions might there be? The clinical research associate (CRA) has the main role and responsibility of carefully selecting fitting investigators, instigates and monitors the clinical trials at the different sites and, monitors the advancement of the study up until completion. In addition, the CRAs are also dispensed the accountability and obligation of thoroughly
Standards Technology Impact on Clinical Research and the Interrelationship of Uniform Data Format Standards With increasing robustness of technology, clinical programmers began realizing inefficiencies in metadata and recreation from scratch each time, in addition to overlapping data elements over research works. Further, they saw the numerous inconsistent techniques for collection of specific, seemingly-simple data elements. The most straightforward example conveying the above challenge is: defining subject gender (Female or Male) in
Changing Role of Data Management in Clinical Trials What do you think the author meant when he wrote, "The EDC/eClinical approach shifts the burden of work to predeployment, and from reactive per instance to proactive per project?" In your response, give specific examples Even as clinical research increases globally, it is imperative to create quality guarantee source, which make certain that data integrity is maintained. Integrating the electronic data capture (EDC) system
CFR-Case report form is the main unit of data compilation in every clinical trial. The model of the CRF design carries and directly influences the success or failure of this study. CRF-case report form is a special document in clinical researches. It ought to be driven by study protocol, rich in content and have necessary material to gather the research specific data. Though paper CRFs are widely in use,