Risk-Based Decisions in Clinical Trial Site Management November 2010

Dec 3, 2010
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Course Description 

All clinical trial teams, sponsors/CROs, investigators/sites, and IRBs/IECs should assess their current practices in order to identify gaps in support of risk-based project decisions. Proactively at the start of the project and during issues management, risk management should be part of a quality system that supports GCPs for each project’s unique challenges. The GCPs alone do not support essential risk-based decisions per unique needs and outcomes of each protocol for each stakeholder (sponsor, vendor, investigator, and ethics committee).

Practices of minimizing documentation of process management of project issues are “risky” and have resulted in the opposite of their intent to minimize impact of project deficiencies. In some cases, these practices have resulted in poor inspection outcomes. Incorporating risk management principles into all stakeholder quality systems aligns with regulatory authorities’ movement to risk-based inspectional approaches.

This course will present how to incorporate risk management process and strategies to current clinical project management systems for all stakeholders.



Learning Objectives 

  • Define quality system levels and applicable areas of clinical site management
  • Define risk management
  • Apply seven risk management strategies in clinical site management
  • Apply risk management tools to case scenarios

Who Should Attend 

  • Sponsor/CRO Study Teams
  • Investigator/CRC Site Study Teams
  • Ethics Committee Members


Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.

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Course Length Time 

2 hours; 12:00 - 2:00 p.m. Eastern

Course Dates 

December 3, 2010                                       

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For more information, contact Naila Ganatra at (215) 413-2471.