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Monitoring Informed Consent March 2010

Mar 29, 2010
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Course Description

Monitoring is one form of checks and balances that research sponsors conduct to help ensure human subject protections and data integrity for their studies. The process of monitoring informed consent is presented, including monitoring the: ICF template content, proper completion, and documentation of the ICF process.  Case examples are presented to promote understanding and stimulate questions for discussion.



Learning Objectives

  • Identify required informed consent template content per regulations, including basic and additional elements
  • Monitor the ICF: Clearly define who and what determines if consent has been adequately executed
  • Monitor the informed consent process documentation throughout the subjects’ time on study

Who Should Attend

  • Clinical Research Associates
  • Research Assistants
  • Project Managers
  • CRA Managers


Sandra ”SAM” Sather, RN, CCRA, CCRC

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Course Length Time

2 hours; 12:30 – 2:30 p.m. Eastern 

Course Dates

March 29, 2010

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