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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.

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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

Instructor

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

Hold this course at your company!

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

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Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)