The Medical Device Coordination Group (MDCG) has published guidance on content for the Clinical Investigation Plans.
What are the key points?
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- Ethical Considerations: Emphasis is placed on adhering to good clinical practice, legal requirements, and ethical standards to safeguard the well-being of study subjects and ensure their protection.
- Content: Each section of a clinical investigation plan is outlined, and detailed explanations are provided.
- Benefit-Risk Analysis: The importance of a complete and thorough benefit-risk analysis is emphasized. Benefits to study subjects need to outweigh the risks.
- Post-Investigation Follow-ups: Guidance on subject management post-participation with particular emphasis on monitoring and care when devices are intended to remain with subject post-study completion.
You can read the entire Clinical Investigation Plan document here.
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If you need assistance in grasping the key elements we’ve listed, or understanding the guidance document published by the MDCG, please contact us so we can help you.