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


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


Download data is not yet available.


1. Vyas, N. R. (2020). Future of risk-based monitoring in clinical trials. International Journal of Clinical Trials, 7(3), 221. https://doi.org/10.18203/2349-3259.ijct20203109.
2. Barnes, B., Stansbury, N., Brown, D., Garson, L., Gerard, G., Piccoli, N., Jendrasek, D., May, N., Castillo, V., Adelfio, A., Ramirez, N., McSweeney, A., Berlien, R., & Butler, P. J. (2021). Risk-Based Monitoring in Clinical Trials: Past, Present, and Future. Therapeutic Innovation & Regulatory Science. https://doi.org/10.1007/s43441-021-00295-8
3. Fneish, F., Schaarschmidt, F., & Fortwengel, G. (2021). Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach. Current Therapeutic Research, 95, 100643. https://doi.org/10.1016/j.curtheres.2021.1006433.
4. Kumawat, J. (2022). Risk Based Monitoring: What is it and How Can You Benefit - Saama. Saama.com. Retrieved 30 July 2022, from https://www.saama.com/risk-based-monitoring-what-is-it-and-how-can-you-benefit/.
5. Jaguste, V., 2022. Risk-based monitoring: Review of the current perceptions and toward effective implementation. [online] Available at: [Accessed 30 July 2022].
6. Agrafiotis, D., Lobanov, V., Farnum, M., Yang, E., Ciervo, J., Walega, M., Baumgart, A. and Mackey, A., 2022. Risk-based Monitoring of Clinical Trials: An Integrative Approach. [online] Available at: [Accessed 30 July 2022].
7. Coogan, A. and Stone, C., 2022. Tackling the Challenges of Transitioning to Risk-Based Monitoring. [online] Applied Clinical Trials Online. Available at: [Accessed 30 July 2022].
8. 21 CFR part 312, subpart D generally (Responsibilities of Sponsors and Investigators) and 21 CFR part 812, subpart C generally (Responsibilities of Sponsors).
9. Guidance for industry Electronic Source Data in Clinical Investigations (September 2013).
10. FDA/CDER/"Purdie, Florine P, A Risk-Based Approach to Monitoring of Clinical Investigations, https://www.fda.gov/media/121479/download
11. FDA’s draft guidance Medical Devices: The Pre-Submission Program and Meetings with FDA Staff. When final, this guidance will represent the FDA’s current thinking on this topic. 35
12. IDE regulations (21 CFR 812.25(e)) require that written monitoring procedures be submitted as part of the IDE application
13. ICH E6, section 5.19, 6, 11 and ISO 14155:2011
14. CDER User, Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, https://www.fda.gov/media/116754/download
177 Views | 63 Downloads
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.
Review Articles