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
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