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Industry Models for Implementing FDA Guidance and Reducing Source Data Verification

November 5-6, 2014
  • Philadelphia, Pennsylvania


Risk-Based Monitoring in Clinical Studies

 

NOVEMBER 5-6, 2014    PHILADELPHIA, PA

 

Gain Strategies to Move Towards a Risk-Based Model
The verification of source documents by study monitors at clinical sites is crucial to ensuring data quality and regulatory compliance. The industry has historically interpreted source data verification (SDV) in the strictest sense with 100% of source documents being verified. Emerging practices being pushed by the FDA, industry and TransCelerate are trending to reduce SDV by implementing a risk-based approach. This in-depth conference provides practical experience, benchmark models and industry case studies, arming attendees with strategies that achieve tremendous time and cost savings.


  Key Reasons to Attend:

  • Understand the expectations laid out in the FDA guidance
  • Learn various approaches to quality risk management
  • Prepare key steps needed to successfully implement
  • Gain insight from industry leaders on case studies that employ various risk-based approaches
  • Identify triggers and critical variables in order to identify risk and effectively facilitate centralized monitoring

 

 

 

 

Risk-Based Monitoring in Clinical Studies

Industry Models for Implementing FDA Guidance and Reducing Source Data Verification


Risk-Based Monitoring in Clinical Studies

 

NOVEMBER 5-6, 2014    PHILADELPHIA, PA

 

Gain Strategies to Move Towards a Risk-Based Model
The verification of source documents by study monitors at clinical sites is crucial to ensuring data quality and regulatory compliance. The industry has historically interpreted source data verification (SDV) in the strictest sense with 100% of source documents being verified. Emerging practices being pushed by the FDA, industry and TransCelerate are trending to reduce SDV by implementing a risk-based approach. This in-depth conference provides practical experience, benchmark models and industry case studies, arming attendees with strategies that achieve tremendous time and cost savings.


  Key Reasons to Attend:

  • Understand the expectations laid out in the FDA guidance
  • Learn various approaches to quality risk management
  • Prepare key steps needed to successfully implement
  • Gain insight from industry leaders on case studies that employ various risk-based approaches
  • Identify triggers and critical variables in order to identify risk and effectively facilitate centralized monitoring