|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?|