Webinar on Focusing Investigational Sites Risks in RBM

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• LIVE WEBINAR Focusing Investigational Sites
  Risks in RBM
• Date/Time Tuesday, 5th April 2016  I  11 AM -
  12 Noon EST Speakers  Sandra 'Sam' Sather, MS,
  BSN, CCRA, CCRC, Clinical Operations Risk
  Expert Ashok Ghone, PhD, VP, Global Services,
  MakroCare

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• Topic of the Webinar
• Sponsors performance of investigational
  site risk assessment is essential for effective
  planning and implementation of clinical trial
  project. Risk identification starts at the
  sponsor/CRO system and project level, and also
  risks are assessed and controlled at site level
  at pre-study and during the trial. The monitoring
  approach and content of the study monitoring plan
  must be based on this risk identification and
  assessment. This webinar will review site risk
  identification, assessment steps and how to
  integrate them into site qualification and into
  the study monitoring plan. This webinar will also
  focus on how to coordinate the sponsor quality
  systems to support risk-based approaches for
  monitoring and oversight.
• Objectives
• Identify key investigational site risk categories
  per project and integration into site
  qualification and monitoring plan development
• Recognize risk management factors to coordinate
  for investigational site oversight risk
  assessment, tracking and controlling
• Importance of centralized monitoring in
  monitoring investigational site risks
• Role responsibilities of central monitor in
  tracking and managing investigational site risks