Make sure you know HIPAA Privacy and Security Rules, and the implications of federal and state laws on privacy and information security, as they relate 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.
Contact Hours/CEUs: 2.25 (ACHE, ACRP, CME, CNE)