New European Union regulations recommend that plain language versions of clinical trial results and protocol synopses be made public. At this webcast, presenters will discuss EU clinical trial regulations, the unique challenges of creating plain language documents for them, and the potential use of these documents to increase health literacy around clinical trials. These include:
- Increased transparency and trust in medical research.
- Improving organizational health literacy of clinical trial sponsors.
- Encouraging collaborative efforts between clinical trial sponsors and patient advocates.
- Empowering patients to make informed decisions about newer medical treatments and enrolling in clinical trials.
- More equitable access to clinical trials
Learning Objectives
- Identify the major design control elements and understand their contribution to the development of safe and effective medical devices.
- Understand how human factors fit into product development and design controls.
- Outline and describe the costs associated with human factors studies.
- Develop strategies for identifying device users, user environments and critical tasks.
- Identify methodological differences between generative, formative, and validation/summative studies.
- Be able to make decisions based on results from human factors studies and document them in the usability engineering file.
Who Should Attend?
- All regulatory affairs professionals
- Product and submission team leads
- Project Managers
- Regulatory and Medical Writers
- Medical and scientific publishing writer
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
