The data quality risks assessment by the FMEA method
DOI:
https://doi.org/10.24959/cphj.15.1353Keywords:
clinical trial, risk management, data quality, risk assessment, FMEAAbstract
Globalization, limited resources, increased complexity and amount of clinical trials (CT), and of participating patients / volunteers create the conditions in which to obtain reliable and scientifically valid results about the effectiveness and safety of medicines is a complex, but a priority task. In this regard, actual is the use of advanced management approaches in the planning and organization of CT of drugs, in particular, quality risk management. The article discusses the methodology of risk assessment for the data quality in clinical trials based on FMEA tools, as well as the results of its testing in Clinical and Diagnostic Center of the National University of Pharmacy. During the development of this method the main types of data quality risks in clinical trial were analyzed, and the basic violations and errors which underlie them were determined. As a result of the expert assessment of the causes and consequences of the identified violations, it was determined the value of data quality risks in clinical trials and their categorization into serious, moderate and minor were executed. It was found that the highest risk is "a lack of understanding by the patient / volunteer questions of an investigator, errors in filling in the diary" the value of which exceeds the level of moderate risk. Based on these results the recommendations to reduce the impact of this risk were given. According to the mentioned above, ease of analysis and interpretation of the results obtained, considered method allows to identify and prevent the threat of violations and errors in data management at the trial site, and it can be used in the risk management process at the planning stage of clinical trials, during audits and regulatory inspections.References
Доброва В.Є., Зупанець К.О., Ратушна К.Л. та ін. // Управління, економіка та забезпечення якості в фармації. – 2013. – №5(31). – С. 16-23.
Доброва В. Є. Аналіз та дослідження ризиків втрати якості даних у клінічному випробуванні / В. Є. Доброва, К. О. Зупанець, К. Л. Ратушна // Клінічна фармація. – 2014. – Т. 18, № 1. – С. 4–10.
Доброва В. Є. Використання імітаційного моделювання для кількісного оцінювання ризиків, пов’язаних із реєстрацією даних у клінічному випробуванні / В. Є. Доброва, К. О. Зупанець, К. Л. Ратушна,// Клінічна фармація. – 2014. – Т. 18, № 4.– С. 23–31.
Клинические испытания лекарств / В. И. Мальцев, Т. К. Ефимцева, Ю. Б. Белоусов и др. ; под ред. В. И. Мальцева. – 2–е изд., перераб. и доп. – К. : МОРИОН, 2006. – 456 с.
Мировой рынок клинических исследований [Електронний ресурс] // Еженедельник Аптека. – 2012. – № 855 (34). – Режим доступу до сайту : http://www.apteka.ua/article/13565
Належна клінічна практика GCP : СТ–Н МОЗУ 42–7.0:2008. – [Чинний від 2009-16-09]. – К. : Міністерство охорони здоров'я України, 2009. – 67 с.
Ратушна К. Л. Розробка методики оцінювання та контролю системи управління даними у клінічних випробуваннях за допомогою ключових показників ризиків / К. Л. Ратушна // Клінічна фармація. – 2015. – Т. 19, № 1. – С. 17–24.
Риск менеджмент – принципы и руководства : ISO 31000:2009 [Електронний ресурс]. – Режим доступу до сайту : http://www.pqm-online.com/assets/files/lib/std/iso_31000-2009%28r%29.pdf
Системи управління якістю. Вимоги. (ISO 9001:2008, IDT) : ДСТУ ISO 9001:2009. – [Чин. від 2009-09-01]. – К. : Держспоживстандарт України, 2009. – 26 с. – (Державний стандарт України).
Управління ризиками для якості : СТ–Н МОЗУ 42–4.2:2011. – К. : Міністерство охорони здоров'я України, 2011. – 26 с.
A guide to the project management body of knowledge [Електронний ресурс]. ‒ Режим доступу до сайту : https://www.pmi.org/pmbok-guide-and-standards/pmbok-guide.aspx
Bhatt A. Quality of clinical trials : a moving target / A. Bhatt // Perspectives in Clinical Research. – 2011. – Vol. 2. – P. 124–8.
McDermott R. E. The basics of FMEA / McDermott R. E., Mikulak R.J., Beauregard M. R. – New York : Taylor & Francis Group, 2009. – 91 p.
Reflection paper on risk based management in clinical trials [Електронний ресурс]. – Режим доступу до сайту : http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf
Risk Management Standard. Institute of Risk Management (IRM) [Електронний ресурс]. – Режим доступу до сайту : http://www.theirm.org/publications/documents/Risk_Management_Standard_030820.pdf
Risk-adapted approaches to the management of clinical trials of investigational medicinal products [Електронний ресурс]. – Режим доступу до сайту : http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/index.html
Downloads
Published
Issue
Section
License
Copyright (c) 2015 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
