ARCHIVED WEBINAR :: FDA's Guidance on Risk-Based Monitoring & What It Means for Clinical Research

Both  sponsors and CROs are trying to determine how to interpret FDA guidance on risk-based monitoring issued in August 2011. In this webinar, we will explore the impact of this guidance on clinical research and provide practical approaches that companies can take to identify risks while still meeting FDA expectations.

  • How the FDA guidance impacts sponsors and CROs today
  • What the FDA expects from a risk assessment
  • Appropriate level of monitoring
  • Questions and approaches used to identify risks
  • The impact on data integrity
  • What  site managers should be considering right now
  • Practical application of the approach, including examples and case scenarios

Featured Presenters:

Kaye Fendt, MSPH, Director of Quality Assurance and Regulatory Compliance at the Duke Clinical Research Institute (DCRI), the world’s largest academic research organization, has almost 30 years of experience including FDA, industry, and academic research. She has taught courses in the Clinical Research Management graduate program at the Duke University School of Nursing and co-developed one of the C omponents of the Office of the National Coordinators Informatics curriculum. She served on the initial Board of Directors of the Clinical Data Interchange Consortium (CDISC) and the Board of the Society of Clinical Data Management.  She has co-authored more than 30 peer-review publications.

Steven Steinbrueck,  MPH, President, Stonebridge GCP Consulting, is an accomplished trainer and writer with a unique professional background that combines clinical research, healthcare, academia and international training. Steve has spoken frequently about ICH Guidelines, Informed Consent, and other critical GCP topics at SoCRA and DIA conferences.


Please Note: This webinar was recorded on August 18, 2012

 

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