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.
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
Vice President of Audit Strategy,
Privacy Regulations: Considerations Before, During, and After the Study
2.25 - ACRP Credits
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