Project 2 - Clinical Investigation Plan
Document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation.
A clinical investigation plan (CIP) is an essential part of any medical device clinical trial. The CIP is a standalone document that includes everything investigators and research staff need to know to successfully undertake the clinical investigation.
The Clinical Investigation Plan (CIP) is the key document in device trials; it is effectively the equivalent of the protocol in a clinical trial. The CIP is defined as follows (ISO, 2003, p. 6): The CIP shall be a document developed by the sponsor and the clinical investigator(s).
The CIP shall be a document developed by the sponsor and the clinical investigator(s). The CIP shall be designed in such a way as to optimise the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfil the objectives of the investigation.
Key elements of the CIP include:
•General information to include a comprehensive list of all the CIs, PIs, coordinating CIs, and investigations centers/sites, name and address of the sponsor, monitoring arrangements, data and quality management, an overall synopsis of the clinical investigation, approval and agreement to the CIP
•Identification and description of the medical device to be investigated
•Preliminary investigations and justification of the study including literature review, preclinical testing, previous clinical experience, and device risk analysis and assessment (this process is described in EN ISO 14971:2007 which is explored in Chapter 6 “Risk Management”)
•Objectives of the clinical investigation
•Design of the clinical investigation
•Statistical considerations
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Deviations from the CIP and how they are handled and recorded
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Amendments to the CIP (ISO, 2003, p. 6–11)
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Adverse events (AEs) and adverse device effects
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Early termination or suspension of the investigation
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Publication policy
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Case report forms (CRF) (the means by which data are captured during the investigation.
clinical investigation plan means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation.
clinical investigation plan means the document (a copy of which is at Appendix 1 and signed by the Investigator) that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the Clinical Investigation and all amendments thereto as the Parties may from time to time agree in accordance with clauses 4.9, 10.2 and 14.2 and which have also been signed by the Investigator. Such amendments will be signed by the Parties and form a part of this Agreement.