FDA RBM Guidance MindMap

FDA RBM Guidance MindMap

Which elements must a Risk-based Monitoring (RBM) plan must contain?
What are the sponsor responsibilities regarding clinical monitoring?
What kind of monitoring methods does the FDA suggest?

To answer these questions, please, explore the MindMap of the “Guidance for Industry. Oversight of clinical Investigations – A Risk-Based Approach to Monitoring (FDA)”. The guidance was published in 2013 and is currently one of the most important regulatory documents for the RBM process.

How to read a MindMap?

  • Start at 12 o’clock and go clockwise.
  • Read deeper levels and meta data if you are interested in details.

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Download the MindMap of the RBM FDA Guidance

 

References:

Guidance for Industry. Oversight of clinical Investigations – A Risk-Based Approach to Monitoring (FDA): http://www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf

By |2016-11-16T18:35:30+00:00July 27, 2016|Blog|0 Comments

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.

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