The growth of technology and data standards has affected data management standards of clinical research in several ways. The most important aspect of standards is the ability to maintain data consistency, a crucial component of a credible research data. However, the reproducibility aspects of clinical data is a critical and validation tool in assessing the consistency of any research studies or clinical trials. Hence, adhering to set standards made it possible to ensure consistency in any reproducible data and maintain the integrity of reproducible data.

To achieve reproducible data, efficient study design, user friendly system and coding format are required in maintaining a better data management in any clinical trial. For instance, the development of clinical data interchange standard consortium (CDISC) and MedDRA codifications/standards provides researcher’s access to common terminologies that are uniform and organized (Carlin, Barton, & Wilkinson, 2012). In addition, standardization of data supports and enhances statistical analysis plan, machine readable description of derivations, accelerates submission format and enhance universal medical communication terminology (Carlin, D., Barton, & Wilkinson, 2012). Furthermore, standardization of data is an efficient and active model design in structuring protocols, clinical trial designs, data and statistical reviews.

Nonetheless, in a globalized clinical study, it is still a challenging task applying standardized terms in remote areas such as developing countries where close link or direct synonym to certain biomedical or clinical trial terms described in the database are missing or complicated. Thus, translation of words with no close relationship to the actual meaning of the intended word may be problematic.

Reference

Carlin, D., Barton, B., & Wilkinson, S. (2012). Data coding and cdisc. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tab_tab_group_id=_2_1&url= %2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id %3D_1958012_1%26url%3D.