Development of the algorithm of adverse events/reactions assessment when conducting clinical trials of drugs

K. O. Zupanets


The most important role of the assessment of undesirable events of drugs takes a special significance in clinical trials when it is important to specify, identify and comprehensively assess the indirect influence of drugs because such information will be the basis for the further stages of clinical trials, as well as future directions of pharmacovigilance. According to the Ukrainian rules of conducting the clinical trial (order #690 from 23 Sept., 2009) adverse reactions (ARs) are considered as those that at least have a causal relationship between medicinal product administrations. At the same time determination of adverse event (AE) is not so definite because sometimes there may be abnormalities, which may appear without drug administration. The analysis of documentation of 17 clinical trials has been performed in order to determine the definitions of AE/AR regarding assessment, registration and control of undesirable manifestations while conducting the clinical trial of new drugs and bioequivalence studies of drugs. As a result of this analysis the discrepancies in the synchronization of information concerning the understanding and assessment of AE/AR among all participants of clinical trials and bioequivalence studies have been found. The corresponding algorithms of the abnormality assessment have been developed by the study investigator with the purpose of the accurate data entry into the case report forms and source documents. These algorithms help to conduct the comprehensive analysis of AE/AR, minimize the number of mistakes during data entry and make the standards of the data entry process, data capture and AE/AR assessment in accordance with international requirements. The implementation of such algorithms in the system of work of the site unit will improve the work of the monitor, as well as the investigator who is responsible for data capture, monitoring and data entry while conducting the clinical trial.


clinical trial; adverse events/reactions; abnormality; data entry


Доброва В.Є., Зупанець І.А. // Клінічна фармація. – 2010. – Т. 14, №3. – С. 11-14.

Дроговоз С.М., Гудзенко А.П., Бутко Я.А. Побочное действие лекарств: Учебник-справочник. – Х.: «СИМ», 2011. – 480 с.

Компендиум 2013 – лекарственные препараты / Под ред. В.Н.Коваленко. – К.: МОРИОН, 2013. – 2360 с.

Мальцев В.И., Ефимцева Т.К., Белоусов Ю.Б. и др. Клинические испытания лекарств / Под ред. В.И.Мальцева. – 2-е изд., перераб. и доп. – К.: МОРИОН, 2006. – 456 с.

Наказ Міністерства охорони здоров’я України №690 від 23.09.2009 у редакції наказу №523 від 12.07.2012.

Bates D.W., Culle D.J., Larid N. et al. // JAMA. – 1995. – Vol. 274 (1). – P. 29-34.

Bhatt A. // Perspectives in Clinical Res. – 2011. – Vol. 2. – P. 124-128.

GCP ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting/ III/3375/93.

International Conference on Harmonisation. ICH Q9: ICH harmonised tripartite guideline: quality risk management. November 9, 2005. (accessed February 1, 2009).

Khosla R., Verma D.D., Kapur A., Khosla S. // Ind. J. Pharm. – 2000. – Vol. 32. – P. 180-186.

Lesar T.S., Briceland L., Stein D.S. // JAMA. – 1997. – Vol. 277 (4). – P. 312-317.

McGuire B., Zupanets I., Lowe M. et al. // Hepatol. – 2010. – №6. – Vol. 51. – P. 2077-2085.

Practical Guide to Quality Management in Clinical Trial Research / Graham D. Ogg – Taylor&Francis Group, 2006. – 205 p.

Robinson M., Cook S. Clinical Trial Risk Management. – Boca Raton: Francis and Taylor, 2006. – 211 p.

Simon D. Dictionary for Clinical Trials. – John Wiley & Sons Ltd, 1999. – 227 p.

Van Mil J.W., Westerlund L.O., Hesberger K.E., Schaefer M.A. // Ann. Pharmacotherapy. – 2004. – Vol. 38 (5). – P. 859-867.

GOST Style Citations

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

Abbreviated key title: Clin. pharm.

ISSN 2518-1572 (Online), ISSN 1562-725X (Print)