Verified Document

Analyzing The Changing Role Of Data Management In Clinical Trials Essay

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 into data management selection is essential to overcoming the burdensome workload experienced in a clinical study. In this aspect, the author of current work took into consideration the contrast between the burden of work in a customary or traditional system of data collection against that of a contemporary electronic data collection (EDC) system.

In particular, the author points out that the burden of work in an EDC system increases substantially at the planning phase also referred to as the designing phase and the subsequent phase of development. Once these critical phases are over, the burden recedes and lessens substantially at the deployment, managing, concluding and locking phase of data collection. On the other hand, in the customary or traditional data collection situation, the burden of work increases considerably someplace within the deployment, management and closing...

The first one is that the EDC system enhances simple and effective data assimilation approach that is both proactive as well as more systematic. This advantage appears in the form of a systematically organized pre-trial data gathering set-up. In addition, another example is in the re-engineering work procedure to obtain an optimum effectiveness and return on investment (Omelu, 2014).
How does the change he describes affect the role and responsibilities of the CRA?

This change described by the author has a significant impact on the roles and responsibilities of the clinical research associate (CRA). In particular, the roles and responsibilities of data entry and data modification are removed from data management and assigned to the clinical research associate (CRA) (Medidata, 2013). Such transfer of responsibility to the CRA aids the data management to take into consideration and concentrate on more value-added activities than solely academic pursuit (Medidata, 2013).

In addition, the CRAs are also delegated with the responsibility to comprehensively and effectively make preparation for monitoring visits and pilot data evaluation and appraisal between visits. The CRAs have the responsible…

Sources used in this document:
References

Medidata. (2013). Capturing the Value of EDC. Medidata Solutions, Inc. Retrieved 4 January 2016 from: https://www.mdsol.com/sites/default/files/RAVE_Capturing-Value-EDC_20131130_Medidata_White-Paper.pdf

Omelu, N. (2014). The Changing Role of Data Management in Clinical Trials with EDC. PharmNest. Retrieved 4 January 2016 from:https://www.pharmnest.com/2014/03/09/the-changing-role-of-data-management-in-clinical-trials-with-edc/

O'Shaughnessy, I. (2007). Strategic Interaction. eClinical. Retrieved 4 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

Pratt, T. (2006). Data Management: R.I.P. or Brave New World? Applied Clinical Trials; Oct 2006; 15, 10; ProQuest Central pg. 58
Cite this Document:
Copy Bibliography Citation

Related Documents

Analyzing and Using Technology in Managing Data in Clinical Trials...
Words: 951 Length: 2 Document Type: Capstone Project

Technology Aid in the Process of Clinical Trials Capstone Project title: Using technology in managing data in clinical trials We will start our paper by discussing "Clinical Data Management" or CDM, which is an important phase in clinical research. It is a process through which reliable, high-quality and statistically accurate data is generated from clinical trials. This drastically reduces the time taken by the process, from when drugs are developed to

Capstone Project Using Technology in Managing Data Within Clinical...
Words: 4518 Length: 12 Document Type: Capstone Project

Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general

Capstone Project Using Technology in Managing Data Within Clinical...
Words: 4518 Length: 7 Document Type: Capstone Project

Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general

Analyzing Standards of Data
Words: 1204 Length: 2 Document Type: Essay

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

Analyzing the Data Monitoring
Words: 756 Length: 2 Document Type: Essay

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

Role of Antibiotic Therapy in the Treatment
Words: 2560 Length: 7 Document Type: Essay

Role of Antibiotic Therapy in the Treatment of Periodontal Disease? The objective of this work is to examine the role of antibiotic therapy in the treatment of periodontal disease. Also examined will be the delivery system, the type of antibiotics and efficacy as an adjunct to mechanical therapy in the management of periodontal disease. Toward this end, this work will examine the literature in this area of study including literature

Sign Up for Unlimited Study Help

Our semester plans gives you unlimited, unrestricted access to our entire library of resources —writing tools, guides, example essays, tutorials, class notes, and more.

Get Started Now