Clinical performance study plan (CPSP)
The clinical performance study plan (CPSP) is developed and applied to ensure that the study is conducted in accordance with the ethical and regulatory requirements and to ensure that data is generated in high quality.
The CPSP is the key document defining and describing e.g. the:
- study purpose
- background and rationale
- IVD medical device under investigation and comparator device
- objectives and endpoints
- study design and procedures
- statistical considerations and sample size
- inclusion and exclusion criteria
- ethical considerations
- adverse event reporting
- data management
- study timeline
- sponsor and study sites
- roles and responsibilities
- quality assurance and quality control
The required content of an CPSP is described in ISO20916 Section 5.5. All study procedures must be conducted in accordance with the CPSP.
