The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation.
The CIP should be detailed enough to serve as a manual for investigators conducting the clinical investigation in a consistent manner across investigational sites and over time. Further, the CIP should allow the competent authorities and ethics committees to assess whether the clinical
investigation has been designed in such a way that potential risks to subjects or third persons, after risk minimization, are justified when weighed against the clinical benefits to be expected.
The CIP should also allow the assessment of whether the reliability and robustness of the data to be generated in the clinical investigation warrants the exposure of subjects to the investigational device and procedures described in the CIP.