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