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Meeting HIPAA & FDA Requirements for Case Histories July 2010

Jul 20, 2010
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Course Description

The HIPAA Privacy Rule has been in effect for some time, but still the FDA clinical investigator’s and Privacy Rule covered entities requirements in many cases are not easily harmonized, supporting adequate original source documentation and individual privacy protections. But both sets of rules can work well with one another, supporting protection for individuals on studies. This session presents common misunderstandings regarding the roles and responsibilities of clinical research sponsors, sites, and IRBs regarding HIPAA & clinical trials. The course also offers sponsors, sites, and IRBs application strategies for improved clinical trial conduct post HIPAA.



Learning Objectives

  • Discuss many of the frequently misunderstood components of the Privacy Rule relating to clinical research source documentation disclosure
  • Answer many of the questions regarding frequently misunderstood components of the Privacy Rule relating to clinical research
  • Describe the latest guidance and notices relating to the Privacy Rule impacting clinical research

Who Should Attend

  • Research Site Trainers
  • Sponsor/CRO Trainers
  • CRAs
  • CRC
  • Quality Assurance
  • Other site study personnel working with study records


Sandra SAM Sather, MS, BSN, CCRA, CCRC

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Course Length Time

1.5 hours; 2:30 - 4:00 p.m. Eastern

Course Dates 

July 20, 2010

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