Description
This Health Insurance Portability and Accountability Act (HIPAA) training for Clinical Research Professionals covers best practices for sites and
sponsors/CROs working together under
HIPAA including use or disclosure of Protected Health Information (PHI) by Covered Entities for research purposes.
HIPAA’s requirements for the use and disclosure of PHI (Protected Health Information) during the conduct of a clinical trial is not simple and depends on the situation. But there is a way to use a core set of principles and questions that provide an ability to manage and facilitate the needs of all stakeholders. The regulatory authority of HIPAA and FDA agree that the two sets of regulations work well together. HIPAA does not restrict the GCP requirements of a site.
This course covers Key Terminology & Concepts Specific to HIPAA and Clinical Trials; Protected Health Information, Assurances for Covered Entities, Authorization vs. Waiver; Security Rule, Privacy Rule, & Enforcement Rule; Sites and Sponsors Working Together Under HIPAA; and extensive real-life interactive case scenarios.
A foundation training applicable for all clinical research professionals involved with the conduct of clinical trials in the United States. This course includes extensive real-life case scenarios with review of example best answers.
