Solutions OP Clinical Trials UK

Enhancing Medical Devices Informed Consent Forms: Discussion With Lydia Ainsworth


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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.

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Solutions OP Clinical Trials UKBy Olga Peycheva