Glossary Term
Clinical Investigation Plan (CIP)
Definition
A Clinical Investigation Plan (CIP) is a detailed document outlining the objectives, design, methodology, and operational aspects of a clinical investigation. It serves as the blueprint for conducting a study to assess the safety, performance, and clinical benefits of a medical device in compliance with regulatory standards and ethical guidelines.
Relevance to the MedTech Industry
The CIP ensures that clinical investigations are conducted systematically and in alignment with regulatory requirements, such as ISO 14155, the EU Medical Device Regulation (MDR), and FDA guidelines. It provides transparency, safeguards participant safety, and generates robust evidence to support the medical device’s regulatory approval and market access.
Additional Information & Related Terms
ISO 14155 An international standard guiding the design and conduct of clinical investigations for medical devices.
Clinical Evaluation Plan (CEP) Defines the broader scope of clinical evaluation, within which the CIP is a key component.
Clinical Investigation The study described and guided by the CIP.
Post-Market Clinical Follow-Up (PMCF) A type of investigation often planned using a CIP to monitor real-world device performance.