Table 7.

Clinical validation in practice.

Documentation you can expect	Documentation of studies should include one or more of: • Clinical study report (CSR) • Regulatory submission (FDA or EMA) • White paper • Published conference proceeding • Published journal article Protocols and study reports should also be made publicly available. The Institutional Review Boards (IRBs) or Ethics Committees (ECs) documentation for the study should also be provided.
Questions answered by clinical validation	Can a BioMeT-derived measurement that has undergone verification and analytical validation steps be used to answer a specific clinical question?