What information should the protocol include to ensure that the investigational IVD study will be scientifically sound?
We recommend that the protocol include a clear description of study design; objectives, estimation of performance goals (e.g., desired confidence interval widths) that are directly related to the intended claims for the IVD device, or hypotheses; and a statistical plan to be applied to the data. (See the Glossary for definitions of protocol, statistical hypothesis, and confidence interval.
Related Questions
- What information should the protocol include to ensure that the investigational IVD study will be scientifically sound?
- Can an investigational IVD device be used outside of the study protocol, in an emergency situation?
- What records should help to ensure scientific soundness of an IVD investigational study?
