Scientific and Practical Substantiation of Ways of Developing and Introducing Electronic Case Report Forms to Ensure the Quality of Bioequivalence Studies

Abstract

Nowadays, in Ukraine the number of clinical trials conducted with the purpose of establishing bioequivalence of domestic drugs to their foreign analogues has increased dramatically. The key establishment which is responsible for collecting data regarding the bioequivalence parameters of drug is the place of study (PS). Source data verification (SDV) is the most common method of quality control at PS, so the higher requirements from the Sponsor to the quality of the research are, the more often the monitor tries to carry out visits to PS to perform SDV. However, contemporary literary sources indicate that the increase in the number of monitoring visits and 100% SDV is unreasonably expensive and doubtfully improve the quality of research. In this article there have been 1050 CRFs of bioequivalence studies, performed in Clinical and Diagnostics Center of National University of Pharmacy, analyzed for corrected errors. Although the results have satisfied us and confirmed the high level of quality control at PS, we would give preference for computer control of technical mistakes especially at a time when several studies are simultaneously carried out at the clinical site and saving time is very important for Investigators. Considering all the aspects of disadvantages of paper CRF usage, an algorithm for the development of e-CRF has been proposed. Implementing the developed e-CRF in the system of Clinical and Diagnostics Center of National University of Pharmacy will obviously help to improve data entry while reducing the number of monitoring visits to the clinical site and save time for Investigators who are involved in the study of bioequivalence of drugs.