Managing Data Release Consent During Post Market Studies
This course outlines the major international legal data protection backgrounds and how they apply to post-market clinical investigations of medical devices. It details the process of signing data release consent forms for clinical investigations, including an overview of the special circumstances involved when subjects cannot read or write or are part of a vulnerable population.
This course is based on the Declaration of Helsinki, the EU Data Protection Directive, and HIPPAA requirements.
Upon successfully completing this course, learners will be able to:
- Effectively manage the process of data release consent forms in a non-interventional post-market clinical investigation
- Ensure compliance with international requirements, including special circumstances
Clinical research associates (monitors), senior clinical research associates, clinical project and compliance managers, clinical quality associates and managers, clinical affairs directors, regulatory affairs managers, clinical investigators, and clinical study coordinators and marketing and sales managers involved in clinical investigations in the post-market phase are all welcome to participate in this course.
Knowledge of HIPPAA and the EU Data Protection Directive is required for professionals wanting to understand the legal background of this process in detail.
Additionally, knowledge of good clinical practice requirements is recommended.