Risk based monitoring in clinical trial-a review

  • Vishal Rastogi Interns, Clinosol Research PVT Ltd, Hyderabad
  • Umasri vijayagiri Interns, Clinosol Research PVT Ltd, Hyderabad
  • Aparna manasa Interns, Clinosol Research PVT Ltd, Hyderabad
  • V.C.Randeep raj SAS Programmer, Visakhapatnam

Abstract

Risk based  monitoring  is  the  targeted approach in clinical trials for maintaining proper data integrity, protection of safety, rights of subjects and good of the trial subjects. The system of onsite monitoring by CRA was time uncontrollable and very effective. But now a day’s technology advancements and pandemic are encouraged to remotely collecting and imaging large data including data tracking site performance. Also enabling identification of trends, risk before selling the drug. The US FDA, proposed these approach of risk based monitoring (RBM). The drive to RBM at assiduity position started in August 2013. These review composition grounded on approach to RBM substantially concentrate on safety of subjects, quality of data and also for quickly and effectively mitigati.ng pitfalls before they compromise trial quality. These paper also provides the information regarding impact of covid19 in clinical trial monitoring and displacements of trial conditioning during the pandemic period. The pandemic situations forced companies to calculate substantially on remote and centralized monitoring due to point closures. The RBM geography check showed remote site monitoring increased and on site monitoring dropped at the peak of the pandemic in April compared with the pre-pandemic. These check also showed that chance of remote point observing visits increased from 18 in February to a high of 93 in April. The check concluded that RBM relinquishment before the COVID- 19 pandemic wasn't as wide as anticipated.

Keywords: Risk based monitoring, clinical trials, US FDA

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References

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Published
12/09/2022
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How to Cite
Rastogi, V., U. vijayagiri, A. manasa, and C. raj V. “Risk Based Monitoring in Clinical Trial-a Review ”. International Journal of Health Care and Biological Sciences, Vol. 3, no. 3, Sept. 2022, pp. 72-79, doi:10.46795/ijhcbs.v3i3.349.
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Review Articles