Week 2 Assignment
There are a number of protocol components that have to be taken into consideration when the investigator is being used. In the operation of a trial and monitor, the protocol components are vital in making sure that the quality of data in the CRF is met as well as the strict adherence to the protocols in place (FDA, 2012; Schultz, 1999). The protocol has to be well defined scientifically. The intended target population has to be well stated as well as the model which should be simple. There ought to be the description of the endpoints and a schedule of the operations taking place. These aspects are vital in order to acquire quality of data.
The data that are applied have to be well managed and evaluated. The administration of the data involves steps on how handle the data. A set of data aspects, evaluation grid and tables for demonstration is necessary. Moreover, an extensive statement with regard to the quality needs is important (Reveiz, Chan, Krleža-Jerić, Granados, Pinart, et al., 2010). The data management has to look into the editing and auditing steps to be applied, ways to estimate the factors in addition to data security and backups.
What is displayed is necessary in regard to a monitor that acquires data. The data that is acquired is ought to be make it possible for data to be acquired in coherence with the performance of the clinical activities, the application of check-boxes and narratives (Fayers and Hays, 2005). The units need to be described while the facility is easy to understand.
In terms of selection of the site and training steps, there has to be the selection of the best. Of more significance is the quality of the staff needed to handle the reports. The training of the staff starts with the investigator’s catalog and goes on to the assessment of the schedule of protocol processes and operation. The investigator meetings are necessary more so I they engage the staff from varied sites who are involved in similar protocol.
References
Fayers, P. and Hays, R., (2005).Assessing Quality of Life in Clinical Trials: Methods and Practice. New York: Oxford University Press
FDA (2012).Establishment and Operation of Clinical Trial Data Monitoring Committees.Guidance for Clinical Trial Sponsors. Retrieved from: http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm127073.pdf
Reveiz L, Chan A-W, Krleža-Jerić K, Granados CE, Pinart M, et al. (2010). Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records. Retrieved from: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0012484
Schultz, J. R. (1999). Data Collection: Presubmission and Submission. Retrieved from: http://www.nap.edu/openbook.php?record_id=9623&page=13
