Enhancing Medical Devices Informe...

Enhancing Medical Devices Informed Consent Forms: Discussion With Lydia Ainsworth

Solutions OP Clinical Trials UK by Olga Peycheva
E33
Sep 5, 2025
25:24

Episode notes

In this episode, we discuss with our Senior Clinical Data Quality Manager, Lydia Ainsworth, our recent publication "Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations"

You can also find our publication translated in Chinese here: Translated version in Chinese

In our discussion we cover why we wrote this review, who the target audience is and how it could help medical devices manufacturers improve their informed consent forms (ICFs). We also talk about some ethical aspects and the checklists that we created as part of our review. It is important to stress that our article is summary of our practical experience and contains a lot of examples that could be very useful when developing (ICFs).

The transcript will be available soon.

Keywords

clinical trials
artificialintelligence
dataprotection
ethics committee
patients involvement
regulations
diversity plans
startups
practicaladvice
clinical research
Good Clinical Practice
informed consent forms
medical devices