Why is it important for the CRA to understand the data management and ? 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 and effectually making groundwork for checking visits and initiate data evaluation and appraisal between visits. The clinical research associates have the liability for making sure that site visits are assured to be devoted and operational. It is imperative for the CRA to understand the data management and statistical analysis plans. This is because if the data entry clerk is not able to understand a field, or if the data appears to be contradictory or evidently improper, a report is directed to the CRA and a query is directed to the site to shed light on or rectify the data entry field being taken into consideration. Therefore, a lack of understanding implies that the CRA will not able to make corrections or rectifications of any problem (Mitchel et al., 2005).
It is imperative to point out that gathering data for the subjects or participants is not an everyday task or responsibility of the principal investigator. In essence, this is more often than not the accountability and task handed out to the clinical research associate (CRA). However, at times, there may perhaps exist some exceptions to this case. This encompasses a number of clinical trials. This is in the case where the final and ultimate accountability with respect to the gathering of data need to shift to the principal investigator. Most of all, however, the clinical research associate ought to be familiar with the data gathering protocol as well as advancement and progress (Clinical Tools, 2012). More so, it is imperative for the CRA to understand the plans being taken into consideration in data management. To be more specific, the responsibility and undertaking of data entry as well as the modification of data that is encompassed in data management are apportioned to the clinical research associate (CRA). The inference of this is that in order for the CRA to handle this responsibility, he or she ought to be well cognizant with statistical analysis plans and data management (Medidata, 2013).
Is it appropriate for the CRA to be involved in the creation and review of these documents? If so, explain why. If not, explain what the exceptions would be and why
It is fitting for the CRA to take part in the creation and assessment of these documents. This is owing to the fact that the CRA has a role that is prompted by the operation of the electronic data collection (EDC) system. This is owing to the fact that it takes into account the role of creating manual queries for the electronic data collection system, , in addition to the augmented accountability for measuring the retorts accomplished from the queries. More so, the CRA is also in a position that enables him or her to evaluate the data remotely by means of the EDC system. For this reason, this ought to diminish the amount of time that is spent at the site. The outcome of this is that it allows time to be more positively and efficaciously used to the undertaking of source data verification (SDV) (O’Shaughnessy, 2007). More so, it is important for the clinical research associate to take part in the cultivation and assessment of these documents for the reason that he or she is responsible for monitoring each and every entry that is made in the case report forms. This is to ascertain that the forms are completed in a proper way and filled up (Krishnankutty, 2012).
Clinical Tools. (2012). Guidelines for in Scientific Research. Retrieved 10 January 2016 from: https://ori.hhs.gov/images/ddblock/data.pdf
Medidata. (2013). Capturing the Value of EDC. Medidata Solutions, Inc. Retrieved 10 January 2016 from: https://www.mdsol.com/sites/default/files/RAVE_Capturing-Value-EDC_20131130_Medidata_White-Paper.pdf
Mitchel, J. T., Ernst, C., Cappi, S., Beasley, W., CCRP, A. L., Kim, Y. J., & You, J. (2005). Changing Roles Of Data Management, Clinical Research, Biostatistics and Project Management When Implementing Internet-Based Clinical Trials.
O’Shaughnessy, I. (2007). . . Retrieved 10 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
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.