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Risk-based monitoring in clinical research
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- Risk-based monitoring in clinical research
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Risk-based monitoring in clinical research
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- RBM is the process of assuring the quality of clinical trials by identifying, analysing, monitoring, and mitigating the risks that might compromise the study’s quality or safety. The US Food and Drug Administration (FDA) recommend three phases in a risk-based monitoring strategy:
- Identify critical data and processes:To correctly monitor a research’s quality and the safety of its participants, the sponsor must understand which components are most vital for each trial, from informed consent to eligibility screening and adverse event tracking.
- Perform a risk assessment:The process of risk assessment includes identifying particular sources of risk and the impact of research mistakes on those risks.
- Develop a monitoring plan:According to FDA guidelines, a monitoring strategy should “explain the monitoring techniques, responsibilities, and requirements of the study”. The program is in charge of informing everyone engaged in the trial’s monitoring of hazards and monitoring methods.
Trial sponsors will be advised to establish a risk-based strategy for clinical trial monitoring by the Integrated Addendum to ICH-GCP E6 (R2). Risk-based monitoring is the name given to this innovative method (RBM). To date, several tools for guiding RBM have been created. However, there is no standard gold technique. RBM tools for clinical trials are relatively new, with a wide range of capabilities and applications. They are still evolving. This makes determining the “best” RBM approach or instrument challenge. Equivalence testing, for example, is necessary to verify whether RBM methods directed by paper-based and SAAS-based RBM tools are equivalent. This study may be included in multi-centre clinical trials and carried out as a SWAT operation (Study within a Trial).[/vc_column_text][vc_column_text]
References
Hurley, Caroline, et al. “Risk-based monitoring (RBM) tools for clinical trials: a systematic review.” Contemporary clinical trials 51 (2016): 15-27.
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