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HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings March 2011

Course Description 

By popular demand HIPAA Team Training has been designed as a course presenting concepts and terminology of HIPAA specific to conducting clinical trials. The course presents the core elements with methodologies for blending the concepts into established clinical trial best practices. The focus of the course is to train sponsor/CROs and site clinical researchers HIPAA concepts for later application in day to day roles.

The course is perfect for new employee orientation and/or initial annual HIPAA training specific to clinical trials. The course is presented in understandable terms, and it is great to take if you never quite understood HIPAA or are confused about what your role involves. Concepts discussed include the HIPAA Privacy Rule and Enforcement Rule specific to clinical research.

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Learning Objectives 

  • Review the History of HIPAA and the Impact on Clinical Research
  • Define Key Terminology and Concepts Specific to HIPAA in Clinical Research
  • Describe Covered Entities Roles and Responsibilities
  • Examine The Enforcement Rule for HIPAA

Who Should Attend 

  • Research Site Managers
  • CRCs/Research Nurses
  • Prinipal Investigators and Sub-Investigator
  • Project Managers and CRA Managers
  • CRAs
  • Regulatory and QA
  • Others involved in use and disclosure of subject data at site or sponsor 

Instructor 

Sandra “SAM” Sather, MS, BSN, CCRA, CCRC

Click here for complete trainer biographies 

Course Length Time 

3 hours; 12:00 - 3:00 p.m. Eastern

Course Dates 

March 18, 2011                                        

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

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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)