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

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

Research & Reviews: Journal of Hospital and Clinical Pharmacy (RROIJ Publishing) is an open access, peer-reviewed journal that focuses and welcomes submissions on all aspects of  not only Hospital and Clinical pharmacy but also in aspects like Drugs & Drug information studies, General anaesthesia, Automatized anaesthesia, Paediatric Anaesthesia, Obstetric Anaesthesia, Neuroanesthesia, All kind of surgeries General medicine & Critical care medicine, Preoperative Evaluation & Postoperative effects, Pain management, Drug information studies, Clinical reviews, Pharmacy practices, Patient care & Counselling, Ischemia reperfusion, Clinical trials, Patient management, Patient care, Nursing, Disease and hospitalization, Trauma care, and Incentive care etc.  

It gives us great pleasure to announce the call for paper on the occasion of 10th Anniversary of the Journal at special and hefty discount of up to 50% on one-time article processing charge. Prospective academicians and scientists are encouraged to utilize this opportunity to get their articles reviewed, processed and published at relatively faster pace and at lower charges. In addition to this, the authors who publish with us during the year-long celebrations will also be eligible for academic awards recommended by the editorial panel.

The Archive page contains wide variety of articles such as Research / Review / Case reports / short communication / Mini review / Prospective / Letter to Editors Etc. We would like introduce a Research article which has been spread to the widest audience of experts; and thus increased in readership, citations and altimetry score.

Title: “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.

To have a glance at the full length manuscript, you can visit us at our archive page and Currently, Journal’s Archive is holding not only normal issues but also focusing on special issues. The purpose of special issues is to publish the most exciting research with respect to the subjects of Hospital and Clinical Pharmacy and to provide a rapid turn-around time regarding reviewing and publishing, and to publicize the articles freely for research, teaching and reference purposes. Submit manuscript of your research articles or special issue articles online through manuscript submission or forwarded to the Editorial Office at clinpharmacy@journaloa.org

Point of Contact

John Robert

Editorial Assistant

Research & Reviews: Journal of Hospital and Clinical Pharmacy

Email: clinpharmacy@journaloa.org