10/19/2021
HIPAA's requirements for the use and disclosure of Protected Health Information (PHI) 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, the OCR and FDA, agree that the two sets of regulations do not conflict and work well together. HIPAA does not restrict the GCP requirements of a site.
Learn the answer to these questions and more in the eLearning course.
Did you know that not all clinical trial sites are covered entities?
How do you know if a clinical research site is a covered entity?
If a site is, do you know what they must do to follow HIPAA requirements to safeguard PHI?
This course covers key terminology and concepts specific to HIPAA and clinical trials, what is and how to protect PHI, assurances for Covered Entities, when a HIPAA Authorization versus a Waiver are used, the differences between the Security Rule, Privacy Rule, & Enforcement Rule, and best practices for sites and sponsors to work together under HIPAA. Extensive real-life interactive case scenarios are included as examples and in-depth practice of the concepts covered.
To purchase to to view an interactive demo, visit our online store HERE.
Learning Objectives
Define key terminology and concepts specific to the HIPAA Privacy Rule in clinical research.
Describe when sites are covered entities and the sponsor roles and responsibilities related to the HIPAA Privacy Rule.
Discuss the requirements of the Privacy Rule relating to clinical research source documentation use and disclosure.
Audience
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.
Customization Available
A fully customized course can be developed for training teams, or for live in person or online workshops. Full LMS compatibility with SCORM packages available. Contact us at info@clinicalpathwaysresearch.com for additional information or to arrange a meeting to discuss.
Enterprise Pricing Available
Off the shelf pricing for over 10 licenses from the store is available when you contact us at info@clinicalpathwaysresearch.com.
Want training for longer than the license timeframe but do not have an LMS? Clinical Pathways can host annual training in our LMS to support your learners, with reports and certificates of completion for audit readiness.
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- The Clinical Pathways Team
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