The current concept of clinical trial conduct is a balance between
benefits from treatment (efficacy) and risks that this treatment may
have (risk). Maxim Kosov, Tatiana Dumpis, Alexey Maximovich,
John Riefler and Maxim Belotserkovskiy, at PSI-CRO, discuss how
the eligibility review is an essential part of risk-based monitoring and
allows mitigation of enrolling non-eligible patients.