ACRP 2018 Meeting & Expo


213 - Privacy Regulations: Considerations Before, During, and After the Study


Apr 29, 2018 10:15am ‐ Apr 29, 2018 12:30pm


Credits: None available.

Members: $25.00
Standard: $75.00
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Description

Make sure you know HIPAA Privacy and Security Rules, and the implications of federal and state laws on privacy and information security, as they related to clinical research. The speaker will identify key challenges and common areas of non-compliance, and the different approaches Institutional Review Boards take to meeting regulatory obligations in this arena and their implications on the research team. Take away an understanding of why the structure of an organization – and the status of the researcher as it relates to the clinical component of the organization – can have implications for how compliance is achieved. This session is a two-part "master series" program.

Learning Objectives:

  • Understand the interplay between the Common Rule, the HIPAA privacy and security regulations and other regulations impacting clinical research
  • Identify key areas of concern and non-compliance regarding privacy and information security in a clinical research project
  • Work effectively with the compliance team of their organization to resolve privacy and information security concerns in research

Speaker(s):

  • Marti Arvin, CHC, CHC-F, CCEP, CCEP-F, CHRC, Vice President of Audit Strategy, CynergisTek

Credits Available


Privacy Regulations: Considerations Before, During, and After the Study

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