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 phase and then progressively deteriorates at locking phase (Pratt, 2006).
There are specific and distinct examples applicable to this case. 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 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 for making certain that site visits are guaranteed to be dedicated and effective (Medidata, 2013).
CRAs also have to bear additional role engendered by the functionality of the EDC system. This encompasses the role of generating manual queries for the electronic data collection system, consolidating finished data-points as well as the increased responsibility for assessing the responses attained from the queries.
In addition, the CRA is also in a vantage position to assess the data tenuously through the EDC system. In turn, this ought to decrease the amount of time employed in the field work. such employment of quality work, permits availability of time to be more successfully and efficaciously deployed to the task of source data verification (SDV) (O’Shaughnessy, 2007).
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). . 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 ? Applied Clinical Trials; Oct 2006; 15, 10; ProQuest Central pg. 58
