Abstract
Clinical trial monitoring involves intensive on-site monitoring visits at clinical trial sites and exhaustive source data verification (monitoring) of clinical trial data [1]. Clinical researchers have questioned the validity and necessity for traditional monitoring methods [2], which have been under investigation due to their ineffectiveness in improving the quality of clinical trial data or in protecting trial participants [3]. Implementing a risk based monitoring (RBM) system is suggested by the ICH’s newly adapted guidelines to improve overall quality management [3]. The RBM involves the identification of any risk that might have an effect on areas routinely subject during monitoring activities. Risks should be identified by a RBM system followed by an evaluation of their likelihood of occurring and the extent to detect these errors and their impact on human subject protection, trial data reliability, and GCP- and protocol compliance [4].
Highlights
Source data verification (Monitoring) is an essential requirement for all clinical trials in phases I-IV as stated by World Health Organization (WHO) guidelines for good clinical practice (GCP) of clinical trials on pharmaceutical products, the Food and Drug Administration (FDA) code of federal regulations, and by the International Council for Harmonization (ICH) [1]
We show that risk based monitoring (RBM) tools result in different overall risk assessment when applied to the same clinical trial protocols, interestingly, each RBM tool detected distinct risks which resulted in a variation in the outcome mitigation
PubMed search engine was used with the terms: risk based monitoring tools, risks assessment of clinical trials where it resulted in 4 pages
Summary
Source data verification (Monitoring) is an essential requirement for all clinical trials in phases I-IV as stated by World Health Organization (WHO) guidelines for good clinical practice (GCP) of clinical trials on pharmaceutical products, the Food and Drug Administration (FDA) code of federal regulations, and by the International Council for Harmonization (ICH) [1]. It has been reported that onsite monitoring is costly with a limited outcome to clinical trial data quality onsite monitoring/SDV [2]. Clinical trial monitoring often involves intensive on-site monitoring visits at clinical trial centers and extensive SDV of clinical trial data [3]. It has been considered to be an expensive, time-consuming and resource demanding activity that does not necessarily improve the quality of clinical trial data or the protection of trial participants [5]
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