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What is Risk-Based Monitoring? Simple Explained.

Electronic Data capturing is developing already for more than 30 years and penetrating the clinical research more and more. Already more than half of all clinical trials are conducted purely electronically, although the process is not yet complete.
Recently did the FDA underlined its wish to support risk-based monitoring in clinical trials with the publication of its August 2011 guidance “Oversight for Clinical Investigations — A Risk Based Approach to Monitoring.” (http://www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf)

The idea is not to monitor sites “flat”, but to do it wisely. I.e. to have risk KPIs in order to understand the pain points of the study. Additionally it would be reasonable to reuse the information from the previous studies in order to benefit the next ones.

Risk-based monitoring is the way, where the pharma company produce more remote monitoring and remote view of the source.

FDA: It’s going to be more centralized and not 100 percent site-specific quality control. There are numerous cost benefits to centralized monitoring including earlier identification of problems that might not be picked up.

By | 2015-10-07T08:37:16+00:00 January 19, 2014|Blog|Comments Off on What is Risk-Based Monitoring? Simple Explained.

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.