COURSE DESCRIPTION

OVERVIEW

In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations – Questions and Answers” which helps support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance. This new guidance contains recommendations on planning your monitoring approach, developing the content of your monitoring plans, and addressing and communicating your results.  While helpful in clarifying the earlier guidance, this draft truly underscores the importance FDA places on work environments and personnel that perform with a risk-based mindset.  While this draft guidance is currently open for comment, it does illuminate what the agency expects from sponsors and the oversight of their trials.

Luckily, we have bridged the gap for you and have many helpful take-aways!

LEARNING OBJECTIVES

Attend this interactive session and you will be able to:

• Identify processes needed to develop a risk-based approach to monitoring plan development
• Recognize components of a risk-based monitoring plan and how to develop one for your specific study
• Apply risk management in developing an agile monitoring plan to respond to expected (and unexpected) site performance
• Apply risk factors to monitoring plan template development (e.g., escalation plans, budgeting, site communications, etc.)
• Recognize key activities for an effective site communication plan