Quality Data...Delivered by Design™

Quality Data...Delivered by Design™

Webinar: Draft Guidance for Industry Oversight of Clinical Investigations - A Risk Based Approach to Monitoring

Course Title

Draft Guidance for Industry Oversight of Clinical Investigations - A Risk Based Approach to Monitoring


This webinar session is scheduled at the customer's convenience. Please call 585-381-1350 x246 to schedule.


This new draft guidance, that was released last summer, replaces the 1988 Monitoring guidance. FDA has updated its monitoring guidance with some of the current monitoring practices, especially those using EDC systems. FDA has retained some existing practices and proposed some “radical” (some say) changes. The guidance proposes that each Sponsor develop a specific monitoring plan for each study based on the study risk and that includes both on-site and “centralized” (or “remote”) monitoring.

Key Points

  • Learn FDA’s new guidance on monitoring
  • Hear how FDA is going to change FDA procedures and auditing guidelines to address this new Risk-Based Monitoring
  • Learn how to develop new types of monitoring plans

Recommended Attendance

  • Sponsors
  • Monitors
  • Clinical Research Associates
  • Project Managers
  • GCP Auditors
  • Regulatory personnel

Instructor Bio

Lorraine D. Ellis, MS, MBA.
Ms. Ellis is an experienced trainer with in-depth knowledge as a result of hands-on experience in clinical trials and training thousands of clinical research professionals over decades. Ms. Ellis has over 30 years clinical research experience and is the author of several books, articles and other clinical research materials. She has authored and taught over 50 courses designed for clinical research professionals.

She has presented at major industry meetings such as DIA, ACRP, CRO Partnerships and others. Ellis has also served as faculty for ACRP courses, participated in the development of ACRP certification programs, and is an adjunct professor in the MS in Clinical Research Management program at Rochester Institute of Technology.


$99 per person

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