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A Clinical Investigation Plan (CIP) is an essential document for any systematic investigation of a medical device that involves one or more human subjects. Together with an application form, the investigator’s brochure, and other information, the CIP has to be submitted to the member state(s) in which the clinical investigation is to be conducted.
The CIP needs to describe at a minimum the rationale, objectives, design, methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation. This plan has to reflect the latest scientific and technical knowledge and allow the confirmation or refutation of the manufacturer’s claims regarding the safety, performance, and aspects relating to benefit-risk of the device.
The CIP serves as a manual for investigators conducting the clinical investigation, allowing the clinical investigation to be performed in a consistent manner across sites and over time. In addition, it should allow the competent authorities and ethics committees to assess the clinical investigation design in terms of potential risks to subjects or third persons after risk minimization, benefit-risk, and reliability and robustness of the data to be generated. The CIP should warrant justified exposure of subjects to the investigational device and planned procedures.
All requirements for the CIP are detailed in Annex XV (Chapter II, Section 3) of the Medical Devices Regulation (2017/745).
Emtex Life Science medical writers can manage and coordinate the document development process (eg, compile contributions, circulate for review, implement comments) and can help to generate a clear, well structured, and coherent document, meeting all regulatory requirements.
FAQ: Clinical Investigation Plan (CIP)
What is a Clinical Investigation Plan (CIP)?
A CIP is the document that describes any systematic investigation of a medical device involving one or more human subjects. The CIP outlines how the clinical investigation will be conducted and how data will be generated and evaluated.
What information does a CIP include?
A CIP includes the rationale for the investigation, the objectives, the study design, the methodology, monitoring procedures, conduct requirements, record‑keeping expectations, and the method of analysis. It defines all essential elements needed to carry out the clinical investigation.
Which regulations describe the requirements for a CIP?
The requirements for a CIP are detailed in Annex XV (Chapter II, Section 3) of the Medical Devices Regulation (2017/745).
How can Emtex Life Science support the preparation of a CIP?
Emtex Life Science can support the CIP process by coordinating contributions from all relevant functions, managing review cycles, implementing comments, and ensuring that the CIP is clearly structured and aligned with regulatory expectations. Emtex can also assist in preparing updates if modifications to the CIP are required.
Why is professional medical writing support valuable for a CIP?
Professional medical writing support is valuable because a CIP must be clear, coherent, and fully aligned with regulatory requirements. A medical writer ensures logical structure, precise wording, and consistency, which strengthens the quality of the documentation supporting the clinical investigation.